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Cystitis, InterstitialPhase 2NCT00999518

A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

A Phase 2 study testing Tanezumab in people with Cystitis, Interstitial, run by Pfizer at 171 sites in 14 countries.

Terminated

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

Official record
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Trial summary

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystitis, Interstitial
What is being tested?
Tanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
171 sitesin 14 countries
Study dates
22 Jan 2010to 21 Jan 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

  • Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
  • Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Who cannot join

  • Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
  • Body mass index (BMI) of >39 kg/m2.
  • History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  • Patients with peripheral neuropathy.
  • Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.

Trial locations and contacts

171 sites in 14 countries.

171 sites in 14 countries

United States122 sites

  • Capital Region Urological Surgeons

    Albany, New York, 12208

  • Institute for Female Pelvic Medicine and Reconstructive Surgery

    Allentown, Pennsylvania, 18103

  • Atlanta Medical Research Institute, LLC

    Alpharetta, Georgia, 30005

  • Northside Hospital Radiology Services (x-ray only)

    Alpharetta, Georgia, 30005

  • Anne Arundel Diagnostics Imaging

    Annapolis, Maryland, 21401

  • Anne Arundel Urology, PA

    Annapolis, Maryland, 21401

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • MRI Imaging of Georgia

    Atlanta, Georgia, 30308

  • MRI Imaging Of Georgia

    Atlanta, Georgia, 30327

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • Access Medical Imaging

    Beverly Hills, California, 90211

  • Boulder Medical Center, PC

    Boulder, Colorado, 80304

  • Visions Clinical Research

    Boynton Beach, Florida, 33472

  • Alpha Clinical Research

    Brighton, Massachusetts, 02135

  • Bristol Urological Associates, PC

    Bristol, Tennessee, 37620

  • TriCities Medical Research

    Bristol, Tennessee, 37620

  • Tri-State Urologic Services PSC, Inc. dba The Urology Group

    Cincinnati, Ohio, 45212

  • Central Ohio Urology Group

    Cofumbus, Ohio, 43221

  • Columbus Urology Research, LLC

    Columbus, Ohio, 43220

  • Georgia Urology

    Decatur, Georgia, 30033

  • Diagnostic Imaging (radiology only)

    Dover, Delaware, 19901

  • Urology Associates of Dover

    Dover, Delaware, 19904

  • CRL Imaging Southdale (x-rays only)

    Edina, Minnesota, 55435

  • Medical Advanced Pain Specialists Applied Research Center Incorporated

    Edina, Minnesota, 55435

  • Deaconess Clinic Downtown Research Institute

    Evansville, Indiana, 47713

  • Genesis Clinical Research and Consulting

    Fall River, Massachusetts, 02720

  • Women's Health Specialty Care

    Farmington, Connecticut, 06032

  • Urology Associates of Central California

    Fresno, California, 93720

  • Canyon State Urology

    Glendale, Arizona, 85306

  • Citrus Valley Medical Research Inc.

    Glendora, California, 91741

  • Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan

    Grand Rapids, Michigan, 49503

  • Matrix Research, LLC

    Greer, South Carolina, 29650

  • The Urology Group

    Greer, South Carolina, 29650

  • Mobley Research Center

    Houston, Texas, 77024

  • Advances In Health, Inc.

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • Centex Research, Inc.

    Houston, Texas, 77062

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Metropolitan Urology

    Jeffersonville, Indiana, 47130

  • HealthCare Midwest

    Kalamazoo, Michigan, 49008

  • Rheumatology PC

    Kalamazoo, Michigan, 49009-2175

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Benedictine Hospital

    Kingston, New York, 12401

  • Hudson Valley Urology, PC

    Kingston, New York, 12401

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • University Urology

    Knoxville, Tennessee, 37920

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • University Urologists

    Lake Worth, Florida, 33461

  • Family Health Care Center (X-Ray)

    Lincoln, Nebraska, 68506

  • Women's Clinic of Lincoln, P.C.

    Lincoln, Nebraska, 68510

  • Atlantic Urology Medical Group

    Long Beach, California, 90806

  • Longmont Clinic, PC

    Longmont, Colorado, 80501

  • Longmont Medical Research Network

    Longmont, Colorado, 80501

  • Institute for Advanced Urology

    Los Angeles, California, 90048

  • The Neurology Clinic

    Memphis, Tennessee, 38018

  • Southeast Urology Network

    Memphis, Tennessee, 38119

  • The West Clinic

    Memphis, Tennessee, 38120

  • Alabama Orthopaedic Clinic

    Mobile, Alabama, 36608

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Urology Northwest

    Mountlake Terrace, Washington, 98043

  • Rocky Mountain Neurological Associates

    Murray, Utah, 84107

  • Salt Lake Surgical Center

    Murray, Utah, 84107

  • Tri Valley Urology Group

    Murrieta, California, 92562

  • Valley Neurology

    Murrieta, California, 92562

  • Specialists in Urology

    Naples, Florida, 34102

  • Access Clinical Trials, Inc (ACT)

    Nashville, Tennessee, 37203

  • Center for Urological Treatment

    Nashville, Tennessee, 37203

  • Diagnostic Health

    Nashville, Tennessee, 37203

  • Swan and Brennan, Incorporated

    Nashville, Tennessee, 37203

  • The Center for Reproductive Health

    Nashville, Tennessee, 37203

  • Grove Hill Clinical Research

    New Britain, Connecticut, 06052

  • Urology Center of Grove Hill

    New Britain, Connecticut, 06052

  • Advanced Urology Associates

    New Port Richey, Florida, 34652

  • Excel Medical Imaging

    New Port Richey, Florida, 34652

  • Urology Specialists of West Florida

    New Port Richey, Florida, 34655

  • University Urology Associates

    New York, New York, 10016

  • Deaconess Clinic Gateway Health Center Research Institute

    Newburgh, Indiana, 47630

  • American Health Network (X-Ray only)

    Noblesville, Indiana, 46062

  • Urology of Indiana, LLC

    Noblesville, Indiana, 46062

  • Advanced Imaging Center Incorporated

    Ocala, Florida, 34471

  • Ocala Urology Specialists

    Ocala, Florida, 34471

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Legacy Clinical Research, LLC

    Oklahoma City, Oklahoma, 73109

  • Jeanes Hospital

    Philadelphia, Pennsylvania, 19111

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Urology Specialists, Ltd.

    Phoenix, Arizona, 85020

  • Central Arizona Urologists

    Phoenix, Arizona, 85021

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Precision Trials, LLC

    Phoenix, Arizona, 85032

  • Valley Radiologists (x-ray only)

    Phoenix, Arizona, 85032

  • Valley Urologic Associates

    Phoenix, Arizona, 85032

  • Gateway Radiology (x-rays only)

    Pinellas Park, Florida, 33781

  • DRA Imaging, PC (X-Rays Only)

    Poughkeepsie, New York, 12601

  • Hudson Valley Urology, PC

    Poughkeepsie, New York, 12601

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Rochester, Department of Urology

    Rochester, New York, 14642

  • Beaumont Hospitals - Royal Oak

    Royal Oak, Michigan, 48073

  • Crescent Medical Research

    Salisbury, North Carolina, 28144

  • Salisbury Urological Clinic

    Salisbury, North Carolina, 28144

  • Salt Lake Regional Medical Center (X-rays only)

    Salt Lake City, Utah, 84102

  • Salt Lake Research, PLLC

    Salt Lake City, Utah, 84107

  • Western Urological Clinic, PC

    Salt Lake City, Utah, 84124

  • Scottsdale Medical Imaging

    Scottsdale, Arizona, 85251

  • Marc Kirschner, MD

    Seattle, Washington, 98133

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Liberty Pacific Medical Imaging

    Signal Hill, California, 90755

  • Southeast Urology Network

    Southaven, Mississippi, 38671

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Brian J. Hines, MD

    Stamford, Connecticut, 06902

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Advanced Research Institute Incorporated

    Trinity, Florida, 34655

  • Michigan Institute of Urology, P.C.

    Troy, Michigan, 48084

  • Radiology Limited (x-ray only)

    Tucson, Arizona, 85711

  • Arizona Urologic Specialists

    Tucson, Arizona, 85712

  • Planned Parenthood of Arkansas and Eastern Oklahoma

    Tulsa, Oklahoma, 74105

  • Oklahoma State University

    Tulsa, Oklahoma, 74127

  • The Iowa Clinic, Medical Imaging

    West Des Moines, Iowa, 50266

  • The Iowa Clinic, Urology

    West Des Moines, Iowa, 50266

  • Midtown Imaging

    West Palm Beach, Florida, 33417

  • Premier Urology

    Westerville, Ohio, 43081

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada8 sites

  • The Gateway 2

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • The Male/Female Health and Research Centre, Royal Court Medical Centre

    Barrie, Ontario, L4M 7G1

  • Centre for Applied Urological Research

    Kingston, Ontario, K7L 3J7

  • Kingston General Hospital

    Kingston, Ontario, K7N 2V7

  • Urology Associates / Urologic Medical Research

    Kitchener, Ontario, N2N 2B9

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Anthony Skehan Medicine Professional Corporation

    Thunder Bay, Ontario, P7E 6E7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Poland5 sites

  • SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii

    Bialystok, 15-950

  • Conti Medica Sp. z o.o.

    Warsaw, 00-846

  • Spoldzielnia Pracy Specjalistow Radiologow

    Warsaw, 01-194

  • NZOZ Centrum Medyczne Wola

    Warsaw, 01-432

  • Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen

    Warsaw, 02-005

Other trials in Poland

Russia5 sites

  • Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology

    Moscow, 105425

  • Urology of Rosmedtechnology

    Moscow, 105425

  • Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology

    Saint Petersburg, 198205

  • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava

    Saint Petersburg, filial 1 197022

  • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology

    Saint Petersburg, filial 1, 197022

Other trials in Russia

Belgium4 sites

  • Universitair Ziekenhuis Brussel

    Brussels, B-1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Japan4 sites

  • Tokyo Women's Medical University Medical Center East

    Arakawa-ku, Tokyo, 116-8567

  • Tokyo University Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Harasanshin Hospital, Urology

    Fukuoka, Fukuoka, 812-0033

  • Kyoto City Hospital, Urology

    Nakagyo-ku, Kyoto-shi, Kyoto, 604-8845

Other trials in Japan

South Korea4 sites

  • Department of Urology, Seoul National University Hospital

    Seoul, 110-744

  • Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

  • Department of Urology, Korea University Anam Hospital

    Seoul, 136-705

  • Department of Urology, Asan Medical Center, University of Ulsan

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • Chang Gung Medical Foundation - Kaohsiung/Department of Surgery

    Koahsiung Hsien, 833

  • Taichung Hospital, Department of Health, Executive Yuan

    Taichung, 403

  • Taipei Veterans General Hospital (X-Ray Only)

    Taipei, 112

  • Taipei Veterans General Hospital/Department of Surgery

    Taipei, 112

Other trials in Taiwan

Romania3 sites

  • Dinu Uromedica SCM

    Bucharest, Sector 4, 041345

  • Spitalul Clinic Prof. Dr. Th. Burghele

    Bucharest, 050653

  • Centrul Medical Sf. Pantelimon

    Pantelimon

Other trials in Romania

Slovakia3 sites

  • Martinska fakultna nemocnica

    Martin, 036 59

  • Univerzitna nemocnica Martin

    Martin, 036 59

  • MILAB s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Spain3 sites

  • Clinica Del Remei - Instituto Medico Tecnologico

    Barcelona, 08024

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

Sweden3 sites

  • Kliniska provningsenheten

    Gothenburg, 413 45

  • Medicinsk Rontgen (x-ray only)

    Malmö, 211 36

  • Center for Lakemedelsprovning Malmo

    Malmö, 211 52

Other trials in Sweden

Hong Kong2 sites

  • Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong

    Shatin, NEW Territories, 0

  • Department of Surgery, The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

Finland1 site

  • Kouvolan Laakariasema

    Kouvola, 45200

Other trials in Finland

About this study

Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels

Read the detailed description

This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

Being tested
Tanezumab, Placebo
Keywords
Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety
Medical subject headings
Cystitis, Interstitial

What participants receive

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

  • TanezumabBiological

    1 mg dose given subcutaneously twice at an 8-week interval.

  • TanezumabBiological

    2.5 mg dose given subcutaneously twice at an 8-week interval.

  • TanezumabBiological

    10 mg dose given subcutaneously twice at an 8-week interval.

  • TanezumabBiological

    20 mg dose given subcutaneously twice at an 8-week interval.

  • PlaceboOther

    Placebo dose given subcutaneously twice at an 8-week interval.

Study groups in NCT00999518
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Biological: Tanezumab
Group 2ExperimentalNot described
Receives: Biological: Tanezumab
Group 3ExperimentalNot described
Receives: Biological: Tanezumab
Group 4ExperimentalNot described
Receives: Biological: Tanezumab
Group 5Placebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Change From Baseline in Mean Average Daily Pain Score at Week 8

    Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

    Measured: Baseline, Week 8

Secondary outcomes (22)

  1. Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

    Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  2. Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score

    Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

    Measured: Week 8, 16

  3. Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

    Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  4. Patient Global Assessment of Health Status Scores

    Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.

    Measured: Baseline, Week 2, 8, 16, 24

  5. Number of Participants With Global Response Assessment Scores

    Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.

    Measured: Week 8, 16, 24

  6. Number of Micturitions Per 24 Hours

    The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  7. Number of Nocturnal Micturitions Per 24 Hours

    The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  8. Number of Micturition-related Urgency Episodes Per 24 Hours

    The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  9. Participant's Urge to Urinate

    Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  10. Mean Voided Volume Per Micturition

    Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24

  11. O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score

    The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.

    Measured: Baseline, Week 2, 8, 16, 24

  12. Brief Pain Inventory-Short Form (BPI-sf) Score

    BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.

    Measured: Baseline, Week 8, 16, 24

  13. Number of Participants With Patient Global Satisfaction Assessment Scores

    Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.

    Measured: Week 8, 16, 24

  14. Number of Participants With Patient Global Preference Assessment Score

    Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.

    Measured: Week 8, 16, 24

  15. Number of Participants With Willingness to Re-use Medicine Assessment

    Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).

    Measured: Week 8, 16, 24

  16. Euro Quality of Life (EQ-5D) - Health State Profile Utility Score

    EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    Measured: Baseline, Week 8, 16, 24

  17. Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score

    PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.

    Measured: Baseline, Week 2, 8, 16, 24

  18. Percentage of Participants Who Received Rescue Medication

    For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  19. Number of Days of Rescue Medication Usage Per Week

    In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  20. Number of Rescue Medication Doses Used Per Week

    In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  21. Amount of Rescue Medication Taken Per Week

    In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

  22. Serum Total Nerve Growth Factor (NGF) Levels

    Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.

    Measured: Baseline, Week 1, 2, 8, 16, 24

Timeline

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

  1. First posted21 Oct 2009 (estimated)
  2. Study start22 Jan 2010
  3. Primary completion17 Nov 2010
  4. Study completion21 Jan 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
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00999518
Sponsor's protocol ID
A4091035
Other IDs
2009-014597-17, 2009
Status last verified
Jul 2021
First submitted
20 Oct 2009
Last updated
3 Aug 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

  • Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

    PubMed 32734597

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tanezumab in people with Cystitis, Interstitial, run by Pfizer at 171 sites in 14 countries.

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 2 inclusion and 5 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Canada, Poland, Russia, Belgium and 9 more countries. 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. Some participants in this study may receive a placebo. 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 3 Aug 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?

Change From Baseline in Mean Average Daily Pain Score at Week 8 (time frame: Baseline, Week 8). 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 NCT00999518, which also lists 1 linked publication.

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 3 Aug 2021.

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