AzTrials
AzTrials

Low Back PainPhase 2NCT00924664

Long Term Safety Study of Tanezumab in Chronic Low Back Pain

A Phase 2 study testing Tanezumab 20 mg and Tanezumab 10 mg in people with Low Back Pain, run by Pfizer at 149 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
Tanezumab 20 mg and Tanezumab 10 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
849 participants
Where
149 sitesUnited States
Study dates
20 Aug 2009to 22 Jun 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent prior to completing any of the study procedures.
  • Female patients must meet one of the following criteria:
  • 1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.
  • 2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing
  • Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
  • Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.
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  • Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Patient has been treated in a parent tanezumab double blind CLBP study
  • Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

Who cannot join

  • Failed screening in a parent tanezumab double blind CLBP study
  • Withdrawn from a parent tanezumab double blind CLBP study for an adverse event
  • Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study
  • Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study
  • Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study
  • Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;
  • Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

Trial locations and contacts

149 sites in 1 country.

149 sites in 1 country

United States149 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Allegheny Pain Management

    Altoona, Pennsylvania, 16602

  • Blair Medical Associates-Radiology

    Altoona, Pennsylvania, 16602

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36201

  • Pinnacle Research Group, Anniston Medical Clinic

    Anniston, Alabama, 36207

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Center for Prospective Outcome Studies

    Atlanta, Georgia, 30327

  • Southeastern Radiology Associates, LLC

    Atlanta, Georgia, 30327

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Office of Peter A. Holt, MD

    Baltimore, Maryland, 21239

  • DiscoveResearch, Inc.

    Beaumont, Texas, 77701

  • Beaumont Internal Medicine & Geriatric Associates

    Beaumont, Texas, 77702

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • The Center for Clinical Trials

    Biloxi, Mississippi, 39531

  • Simon Williamson Clinic, PC

    Birmingham, Alabama, 35211

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • Selah Medical Center, PA

    Boise, Idaho, 83704

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • Paramount Clinical Research

    Bridgeville, Pennsylvania, 15017

  • DiscoveResearch Incorporated

    Bryan, Texas, 77802

  • Providence Clinical Research

    Burbank, California, 91505

  • Punzi Medical Center

    Carrollton, Texas, 75006

  • Phoenix Diagnostic Imaging

    Chandler, Arizona, 85224

  • Radiant Research - Phoenix Southeast

    Chandler, Arizona, 85224

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Southeast Clinical Research, LLC

    Chiefland, Florida, 32626

  • Southeast Clinical Research

    Chiefland, Florida, 32626

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Columbia Arthritis Center, P.A.

    Columbia, South Carolina, 29204

  • Southern Orthopaedic Sports Medicine

    Columbia, South Carolina, 29204

  • New England Center for Clinical Research

    Cranston, Rhode Island, 02920

  • KRK Medical Research

    Dallas, Texas, 75230

  • Doctors Medical Center

    DeFuniak Springs, Florida, 32435

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • SJS Clinical Research, Inc.

    Destin, Florida, 32541

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Advanced Diagnostic Imaging (ADI)

    Evansville, Indiana, 47714

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Valley Research

    Fresno, California, 93720

  • Collaborative Neuroscience Network, Inc.

    Garden Grove, California, 92845

  • SCRI Research Center, LLC

    Germantown, Tennessee, 38138

  • Wolf River Medical Group, LLC

    Germantown, Tennessee, 38138

  • Greensboro Imaging

    Greensboro, North Carolina, 27407

  • Pharmquest

    Greensboro, North Carolina, 27408

  • Radiant Research

    Greer, South Carolina, 29651

  • Advances In Health, Inc.

    Houston, Texas, 77030

  • St. Luke's Diagnostic & Treatment Center Kirby Glen

    Houston, Texas, 77030

  • Centex Research Inc.

    Houston, Texas, 77062

  • Centex Research

    Houston, Texas, 77065

  • Simon-Williamson Clinic, PC

    Hueytown, Alabama, 35023

  • Saadat Ansari, MD

    Huntsville, Alabama, 35801

  • Clinical Research Center of Jackson

    Jackson, Mississippi, 39202

  • Physician's Surgery Center

    Jackson, Mississippi, 39202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Southeast Clinical Research, LLC

    Jacksonville, Florida, 32216

  • Advanced Therapeutics, Inc.

    Johnson City, Tennessee, 37601

  • University of California San Diego

    La Jolla, California, 92121

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Mirkil Medical

    Las Vegas, Nevada, 89119

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Caldwell Memorial Hospital

    Lenoir, North Carolina, 28645

  • Northstate Clinical Research, PLLC

    Lenoir, North Carolina, 28645

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Little Rock Family Practice Clinic

    Little Rock, Arkansas, 72205

  • Samaritan Center for Medical Research Medical Group

    Los Gatos, California, 95032

  • Commonwealth Biomedical Research

    Madisonville, Kentucky, 42431

  • Central New York Clinical Research

    Manlius, New York, 13104

  • CT: Marietta Imaging Center LLC

    Marietta, Georgia, 30060

  • Drug Studies America

    Marietta, Georgia, 30060

  • Medford Medical Clinic, LLP

    Medford, Oregon, 95704

  • Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Sunstone Research

    Medford, Oregon, 97504

  • Simon Med

    Mesa, Arizona, 85202

  • Alabama Orthopaedic Clinic

    Mobile, Alabama, 36608

  • Horizon Research Group

    Mobile, Alabama, 36608

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • Collier Neurologic Specialists

    Naples, Florida, 34102

  • Centex Research

    Nassau Bay, Texas, 77058

  • Medex Healthcare Research

    New York, New York, 10004

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Newport Diagnostic Center

    Newport Beach, California, 92660

  • Chesapeake Regional Imaging Center-Kempsville

    Norfolk, Virginia, 23502

  • Hampton Road Center for Clinical Research

    Norfolk, Virginia, 23502

  • North County Clinical Research (NCCR)

    Oceanside, California, 92056

  • Christine Codding, MD

    Oklahoma City, Oklahoma, 73103

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • McBride Clinic, Inc

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Diagnostic Imaging Centers

    Overland Park, Kansas, 66211

  • Palm Beach Gardens Open Imaging Center

    Palm Beach Gardens, Florida, 33410

  • University Clinical Research

    Pembroke Pines, Florida, 33024

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • Sun Radiology

    Peoria, Arizona, 85381

  • CRI Worldwide LLC

    Philadelphia, Pennsylvania, 19139

  • Arizona Research Center, LLC

    Phoenix, Arizona, 85023

  • Advent Clinical Research Center

    Pinellas Park, Florida, 33781

  • Summit Research Network (Oregon), Inc.

    Portland, Oregon, 97210

  • Clinical Trials Technology, Inc.

    Prairie Village, Kansas, 66206

  • Wake Internal Medicine Consultants, Inc.

    Raleigh, North Carolina, 27612

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Advances in Medicine

    Rancho Mirage, California, 92270

  • Health Concepts

    Rapid City, South Dakota, 57702

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • B & I Imaging

    Rochester, New York, 14609

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Trinity Medical Research

    Roseville, California, 95661

  • Center for Clinical Trials of Sacramento, Inc.

    Sacramento, California, 95823

  • J. Lewis Research, Inc.

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Incorporated/Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Paragon Research Center

    San Antonio, Texas, 78205

  • Office of Theresia Lee, MD

    San Antonio, Texas, 78229

  • Progressive Clinical Research

    San Antonio, Texas, 78229

  • Sendero Imaging and Treatment Center

    San Antonio, Texas, 78229

  • Wetlin Research Associates, Inc

    San Diego, California, 92120

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Scottsdale Medical Imaging

    Scottsdale, Arizona, 85251

  • Miami Research Associates

    South Miami, Florida, 33143

  • Clinvest, A Division of Banyan Group, Inc

    Springfield, Missouri, 65807

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Meridien Research

    St. Petersburg, Florida, 33709

  • St Petersburg General Hospital - X-Rays only

    St. Petersburg, Florida, 33710

  • Dale G. Bramlet, MD., P.L.

    St. Petersburg, Florida, 33713

  • Advanced Radiology

    Stamford, Connecticut, 06902

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Booth Radiology

    Stratford, New Jersey, 08084

  • Premiere Phamaceutical Research, LLC

    Tempe, Arizona, 85282

  • Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC

    Tempe, Arizona, 85283

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Cotton-O'Neil Clinic

    Topeka, Kansas, 66606

  • New England Research Associates, LLC

    Trumbull, Connecticut, 06611

  • Inland Rheumatology & Osteoporosis Medical Group, Inc.

    Upland, California, 91786

  • Virginia Beach Radiology

    Virginia Beach, Virginia, 23454-3033

  • Advanced Pain Management

    Virginia Beach, Virginia, 23454

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Palm Beach Research Center

    West Palm Beach, Florida, 33404

  • MD Now Urgent Care

    West Palm Beach, Florida, 33409

  • Midtown Imaging

    West Palm Beach, Florida, 33417

  • Elite Clinical Trials, Inc.

    Wildomar, California, 92595

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • CRI Worldwide, LLC

    Willingboro, New Jersey, 08046

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN

The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.

Read the detailed description

This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

Conditions
Low Back Pain
Being tested
Tanezumab 20 mg, Tanezumab 10 mg
Keywords
low back pain monoclonal antibody nerve growth factor
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tanezumab 20 mgBiological

    Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

  • Tanezumab 10 mgBiological

    Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks

Study groups in NCT00924664
Study groupRoleWhat they receive
Tanezumab 20 mgExperimentalNot described
Receives: Biological: Tanezumab 20 mg
Tanezumab 10 mgExperimentalNot described
Receives: Biological: Tanezumab 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.

    Measured: Baseline up to 112 days after last dose of study treatment (up to 448 days)

  2. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 4

  3. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 8

  4. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 16

  5. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 24

  6. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 32

  7. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 40

  8. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 48

  9. Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56

    NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 56

  10. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 4

  11. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 8

  12. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 16

  13. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 24

  14. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 32

  15. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 40

  16. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 48

  17. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

    Measured: A4091012: Baseline, A4091039: Week 56

  18. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 4

  19. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 8

  20. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 16

  21. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 24

  22. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 32

  23. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 40

  24. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 48

  25. Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56

    BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

    Measured: A4091012: Baseline, A4091039: Week 56

  26. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 4

  27. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 8

  28. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 16

  29. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 24

  30. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 32

  31. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 40

  32. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 48

  33. Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56

    RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

    Measured: A4091012: Baseline, A4091039: Week 56

  34. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 4

  35. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 8

  36. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 16

  37. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 24

  38. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 32

  39. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 40

  40. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 48

  41. Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56

    Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

    Measured: A4091012: Baseline, A4091039: Week 56

Secondary outcomes (3)

  1. Time to Discontinuation Due to Lack of Efficacy

    Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

    Measured: Baseline up to Week 56

  2. Plasma Concentration of Tanezumab

    Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.

    Measured: Baseline (Day 1), Week 8, 24, 40, 56, 64

  3. Total Nerve Growth Factor (NGF) Concentration

    Measured: Baseline (Day 1), Week 8, 24, 40, 56, 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2009 (estimated)
  2. Study start20 Aug 2009
  3. Primary completion30 Nov 2010
  4. Study completion22 Jun 2011

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
849 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00924664
Sponsor's protocol ID
A4091039
Other IDs
CLBP SAFETY EXTENSION OF 1012
Status last verified
Mar 2021
First submitted
18 Jun 2009
Last updated
21 Apr 2021
Data monitoring committee
Yes
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

    PubMed 26554876

  • Gimbel JS, Kivitz AJ, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain. 2014 Sep;155(9):1793-1801. doi: 10.1016/j.pain.2014.06.004. Epub 2014 Jun 14.

    PubMed 24937440

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tanezumab 20 mg and Tanezumab 10 mg in people with Low Back Pain, run by Pfizer at 149 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 112 days after last dose of study treatment (up to 448 days)). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.

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