AzTrials
AzTrials

PainPhase 4ACCESS 2008NCT00640042

Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza

A Phase 4 study testing morphine sulfate extended release capsules in people with Pain, run by Pfizer at 384 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Pain
What is being tested?
morphine sulfate extended release capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,570 participants
Where
384 sitesin 2 countries
Study dates
Mar 2008to Dec 2008
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is an adult (greater than or equal to 21 years old
  • Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at the discretion of the Investigator, requires an around-the-clock opioid for optimal analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an 11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable side effects to sustained release opioids or short-acting opioids.
  • Patient is able to read and understand English and comply with protocol requirements.

Who cannot join

  • A patient who meets ANY of the following exclusion criteria will not be enrolled:
  • Hypersensitivity to morphine, morphine salts, or any components of AVINZA
  • Respiratory depression (slowed breathing)
  • Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
  • Currently has or is suspected of having paralytic ileus
  • Requires a daily dose of AVINZA greater than 1600mg/day
Show all 15Show fewer
  • Patient is abusing alcohol
  • Pregnancy or breast feeding
  • Currently taking AVINZA
  • Patient unwilling to sign the Treatment Agreement
  • Life expectancy is less than 2 months
  • Migraine as the primary pain score
  • Patient resides in a hospital or nursing home
  • Patient has had more than 2 surgeries for low back pain
  • Patient is anticipated to require major surgery or steroid injections for chronic pain over the next 12 weeks

Trial locations and contacts

384 sites in 2 countries.

306 sites in 2 countries

United States300 sites

  • Study site

    Adamsville, Alabama, 35005

  • Study site

    Akron, Ohio, 44304

  • Study site

    Akron, Ohio, 44310

  • Study site

    Aliquippa, Pennsylvania, 15001

  • Study site

    Anderson, Indiana, 46011

  • Study site

    Anderson, Indiana, 46012

  • Study site

    Anderson, Indiana, 46016

  • Study site

    Annandale, Virginia, 22003

  • Study site

    Apopka, Florida, 32703

  • Study site

    Archbald, Pennsylvania, 18403

  • Study site

    Arlington, Texas, 76012

  • Study site

    Ashburn, Virginia, 20147

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Ashland City, Tennessee, 37015

  • Study site

    Ashtabula, Ohio, 44004

  • Study site

    Aston Mills, Pennsylvania, 19014

  • Study site

    Atco, New Jersey, 08004

  • Study site

    Augusta, Georgia, 30906

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Avoca, Pennsylvania, 18641

  • Study site

    Bala-Cynwyd, Pennsylvania, 19004

  • Study site

    Ballwin, Missouri, 63011

  • Study site

    Baltimore, Maryland, 21208

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Blackwood, New Jersey, 08012

  • Study site

    Bloomfield, New Jersey, 07003

  • Study site

    Bloomfield Hills, Michigan, 48302

  • Study site

    Bowling Green, Ohio, 43402

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brigantine, New Jersey, 08203

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brooklyn, New York, 11232

  • Study site

    Burlingame, California, 94010

  • Study site

    Camden, South Carolina, 29020

  • Study site

    Canal Winchester, Ohio, 43110

  • Study site

    Cape Coral, Florida, 33990

  • Study site

    Cape Girardeau, Missouri, 63701

  • Study site

    Carbondale, Pennsylvania, 18407

  • Study site

    Castro Valley, California, 94546

  • Study site

    Cave Spring, Georgia, 30124

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Charleston, South Carolina, 29464

  • Study site

    Chester, Maryland, 21619

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chicora, Pennsylvania, 16025

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clarks Summit, Pennsylvania, 18411

  • Study site

    Clarkston, Michigan, 48346

  • Study site

    Clinton, Illinois, 61727

  • Study site

    Clinton, Michigan, 49236

  • Study site

    Clinton, Missouri, 64735

  • Study site

    Cold Spring, Minnesota, 56320

  • Study site

    Collegeville, Pennsylvania, 19426

  • Study site

    Collierville, Tennessee, 38017

  • Study site

    Colorado Springs, Colorado, 80919

  • Study site

    Columbia, South Carolina, 29219

  • Study site

    Conneaut Lake, Pennsylvania, 16316

  • Study site

    Conyers, Georgia, 30013

  • Study site

    Covington, Georgia, 30016

  • Study site

    Cowansville, Pennsylvania, 16218

  • Study site

    Crestwood, Illinois, 60445

  • Study site

    Creve Coeur, Illinois, 61610

  • Study site

    Cuyahoga Falls, Ohio, 44223

  • Study site

    Danville, Illinois, 61832

  • Study site

    Dayton, Ohio, 45410

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Dearborn, Michigan, 48126

  • Study site

    Dearborn Heights, Michigan, 48127

  • Study site

    Decatur, Georgia, 30034

  • Study site

    Defiance, Ohio, 43512

  • Study site

    DeKalb, Illinois, 60115

  • Study site

    DeLand, Florida, 32720

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Deltona, Florida, 32725

  • Study site

    Denver, Colorado, 80220

  • Study site

    Denver, Colorado, 80239

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    Downingtown, Pennsylvania, 19335

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Drexel Hill, Pennsylvania, 19026

  • Study site

    Drums, Pennsylvania, 18222

  • Study site

    Dublin, Pennsylvania, 18917

  • Study site

    Dunnellon, Florida, 34432

  • Study site

    Dyersburg, Tennessee, 38024

  • Study site

    East Orange, New Jersey, 07018

  • Study site

    Edmonds, Washington, 98020

  • Study site

    Elizabeth, Pennsylvania, 15037

  • Study site

    Elkins Park, Pennsylvania, 19027

  • Study site

    Elmwood Park, Illinois, 60707

  • Study site

    Estacada, Oregon, 97023

  • Study site

    Estero, Florida, 33928

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Eustis, Florida, 32726

  • Study site

    Evansville, Indiana, 47712

  • Study site

    Fairfax, Virginia, 22030

  • Study site

    Fairfax, Virginia, 22033

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    Falls Church, Virginia, 22046

  • Study site

    Farmington Hills, Michigan, 48375

  • Study site

    Florence, Kentucky, 41042

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Flossmoor, Illinois, 60422

  • Study site

    Ford City, Pennsylvania, 16226

  • Study site

    Fort Collins, Colorado, 80524

  • Study site

    Fort Collins, Colorado, 80525

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Franklin, Indiana, 46131

  • Study site

    Fremont, Ohio, 43420

  • Study site

    Gahanna, Ohio, 43230

  • Study site

    Genoa, Ohio, 43430

  • Study site

    Georgetown, Delaware, 19947

  • Study site

    Glendale, New York, 11385

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Green Brook, New Jersey, 08812

  • Study site

    Greensburg, Pennsylvania, 15601

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hamilton, Ohio, 45013

  • Study site

    Hamilton, Ohio, 45015

  • Study site

    Havre de Grace, Maryland, 21078

  • Study site

    Hazelwood, Missouri, 63043

  • Study site

    Hemet, California, 92543

  • Study site

    Henderson, Nevada, 89015

  • Study site

    Henderson, Nevada, 89074

  • Study site

    Hendersonville, Tennessee, 37075

  • Study site

    Hermitage, Tennessee, 37076

  • Study site

    Highland, Indiana, 46322

  • Study site

    Honesdale, Pennsylvania, 18431

  • Study site

    Huntington, West Virginia, 25705

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Irving, Texas, 75061

  • Study site

    Irvington, New Jersey, 07101

  • Study site

    Irvington, New Jersey, 07111

  • Study site

    Iselin, New Jersey, 08830

  • Study site

    Jacksonville, North Carolina, 28546

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Jersey City, New Jersey, 07304

  • Study site

    Jersey City, New Jersey, 07306

  • Study site

    Kansas City, Kansas, 66106

  • Study site

    Kansas City, Kansas, 66112

  • Study site

    Kansas City, Kansas, 66172

  • Study site

    Kansas City, Missouri, 64112

  • Study site

    Kansas City, Missouri, 64133

  • Study site

    Kansas City, Missouri, 64151

  • Study site

    Kansas City, Missouri, 64158

  • Study site

    Kenilworth, New Jersey, 07033

  • Study site

    Kenmore, New York, 14217

  • Study site

    Kent, Ohio, 44240

  • Study site

    King of Prussia, Pennsylvania, 19406

  • Study site

    Kingston, Ohio, 45644

  • Study site

    La Porte, Indiana, 46350

  • Study site

    Lake Oswego, Oregon, 97035

  • Study site

    Lakewood, California, 90712

  • Study site

    Lakewood, New Jersey, 08701

  • Study site

    Lancaster, Ohio, 43130

  • Study site

    Lansing, Kansas, 66043

  • Study site

    Lansing, Michigan, 48906

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Lansing, Michigan, 48911

  • Study site

    Lansing, Michigan, 48917

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lawrenceburg, Indiana, 47025

  • Study site

    Layton, Utah, 84041

  • Study site

    Layton, Utah, 94041

  • Study site

    Le Claire, Iowa, 52753

  • Study site

    Lebanon, Tennessee, 37087

  • Study site

    Leslie, Michigan, 49251

  • Study site

    Levittown, Pennsylvania, 19055

  • Study site

    Livermore, California, 94550

  • Study site

    Livonia, Michigan, 48152

  • Study site

    Lockport, Illinois, 60491

  • Study site

    London, Kentucky, 40741

  • Study site

    Los Gatos, California, 95032

  • Study site

    Louisville, Kentucky, 40258

  • Study site

    Loxahatchee Groves, Florida, 33470

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    Maitland, Florida, 32751

  • Study site

    Manchester, Connecticut, 06040

  • Study site

    Margate, Florida, 33063

  • Study site

    Marion, South Carolina, 28571

  • Study site

    Marion, South Carolina, 29571

  • Study site

    Marysville, Washington, 98270

  • Study site

    Maryville, Illinois, 62062

  • Study site

    Mason, Michigan, 48854

  • Study site

    Maumee, Ohio, 43537

  • Study site

    Mays Landing, New Jersey, 08330

  • Study site

    Mayville, New York, 14757

  • Study site

    McKeesport, Pennsylvania, 15131

  • Study site

    McKenzie, Tennessee, 38201

  • Study site

    Memphis, Tennessee, 38122

  • Study site

    Mexico, Missouri, 65265

  • Study site

    Miami, Florida, 33176

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Millburn, New Jersey, 07041

  • Study site

    Millburn, New Jersey, 07083

  • Study site

    Milton, Delaware, 19968

  • Study site

    Milwaukee, Wisconsin, 53208

  • Study site

    Milwaukee, Wisconsin, 53216

  • Study site

    Milwaukie, Oregon, 97222

  • Study site

    Monticello, Kentucky, 42633

  • Study site

    Montrose, Pennsylvania, 18801

  • Study site

    Moon Township, Pennsylvania, 15108

  • Study site

    Morrisville, Pennsylvania, 19067

  • Study site

    Morton, Illinois, 61550

  • Study site

    Mount Pleasant, Pennsylvania, 15666

  • Study site

    Mount Vernon, Missouri, 65712

  • Study site

    Mt. Dora, Florida, 32757

  • Study site

    Murrieta, California, 92562

  • Study site

    Murrieta, California, 92563

  • Study site

    Muskegon, Michigan, 49441

  • Study site

    Muskegon, Michigan, 49444

  • Study site

    Naperville, Illinois, 60540

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37220

  • Study site

    Nevada City, California, 95959

  • Study site

    New Castle, Pennsylvania, 16101

  • Study site

    New Haven, Connecticut, 06511

  • Study site

    New Lexington, Ohio, 43764

  • Study site

    New Smyrna Beach, Florida, 32168

  • Study site

    New Wilmington, Pennsylvania, 16142

  • Study site

    New York, New York, 10019

  • Study site

    New York, New York, 10021

  • Study site

    Newburgh, Indiana, 47630

  • Study site

    Newport, Tennessee, 37821

  • Study site

    Newton, Iowa, 50208

  • Study site

    Norristown, Pennsylvania, 19401

  • Study site

    North Haven, Connecticut, 06473

  • Study site

    North Miami Beach, Florida, 33179

  • Study site

    Northglenn, Colorado, 80234

  • Study site

    Northville, Michigan, 48167

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Nutley, New Jersey, 07110

  • Study site

    Oak Park, Illinois, 60304

  • Study site

    Oak Park, Illinois, 60707

  • Study site

    Oakland, California, 94609

  • Study site

    Oakland Park, Florida, 33308

  • Study site

    Ocean City, Maryland, 21842

  • Study site

    Okemos, Michigan, 48664

  • Study site

    Okemos, Michigan, 48864

  • Study site

    Oldsmar, Florida, 34677

  • Study site

    Olympia, Washington, 98506

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Oregon City, Oregon, 97045

  • Study site

    Orlando, Florida, 32804

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Owosso, Michigan, 48867

  • Study site

    Pekin, Illinois, 61554

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Peoria, Illinois, 61605

  • Study site

    Peoria, Illinois, 61614

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Philadelphia, Pennsylvania, 19124

  • Study site

    Philadelphia, Pennsylvania, 19128

  • Study site

    Philadelphia, Pennsylvania, 19134

  • Study site

    Philadelphia, Pennsylvania, 19145

  • Study site

    Philadelphia, Pennsylvania, 19147

  • Study site

    Philadelphia, Pennsylvania, 19148

  • Study site

    Philadelphia, Pennsylvania, 19152

  • Study site

    Phoenix, Arizona, 85044

  • Study site

    Phoenixville, Pennsylvania, 19460

  • Study site

    Pickerington, Ohio, 43147

  • Study site

    Pigeon, Michigan, 48755

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Pittsburgh, Pennsylvania, 15226

  • Study site

    Pittsburgh, Pennsylvania, 15236

  • Study site

    Pittsburgh, Pennsylvania, 15239

  • Study site

    Platte City, Missouri, 64079

  • Study site

    Port Jefferson Station, New York, 11776

  • Study site

    Port Richey, Florida, 34668

  • Study site

    Portland, Oregon, 97202

  • Study site

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97220

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Raymore, Missouri, 64083

  • Study site

    Reston, Virginia, 20190

  • Study site

    Rexburg, Idaho, 83440

  • Study site

    Rochester, New York, 14615

  • Study site

    Rochester Hills, Michigan, 48306

  • Study site

    Rocklin, California, 95677

  • Study site

    Rome, Georgia, 30165

  • Study site

    Royal Palm Beach, Florida, 33411

  • Study site

    Royersford, Pennsylvania, 19468

  • Study site

    Rushville, Indiana, 46173

  • Study site

    Rusk, Texas, 75785

  • Study site

    Russell Springs, Kentucky, 42642

  • Study site

    Sacramento, California, 95821

  • Study site

    Saint Charles, Missouri, 63301

  • Study site

    Saint Joseph, Missouri, 64506

  • Study site

    Salem, Oregon, 97301

  • Study site

    San Diego, California, 92108

  • Study site

    San Francisco, California, 94115

  • Study site

    Scotch Plains, New Jersey, 08826

  • Study site

    Scottsdale, Arizona, 85258

Other trials in United States

Puerto Rico6 sites

  • Study site

    Carolina, 00986

  • Study site

    Cidra, 00739

  • Study site

    Hato Rey, 00917

  • Study site

    Juncos, 00777

  • Study site

    Ponce, 00717

  • Study site

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes

The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Read the detailed description

Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.

Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.

This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.

Conditions
Pain
Being tested
morphine sulfate extended release capsules
Keywords
pain, opioid, abuse, moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
Medical subject headings
Pain

What participants receive

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

  • morphine sulfate extended release capsulesDrug

    Also called AVINZA

    30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.

Study groups in NCT00640042
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: morphine sulfate extended release capsules

What is being measured

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

  1. Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)

    Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3

    Measured: Baseline (Week 0) to Visit 3 (Week 6)

  2. Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)

    Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4

    Measured: Baseline (Week 0) to Visit 4 (Week 10)

  3. Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)

    Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study

    Measured: Baseline (Week 0) to Visit 5 (Week 14 / End of Study)

  4. Number of Subjects With Treatment Emergent Adverse Events

    Adverse events that occur or worsen after the first dose of Avinza

    Measured: Up to 4 months

  5. Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)

    Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.

    Measured: Visit 3 (Week 6)

  6. Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)

    Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.

    Measured: Visit 4 (Week 10)

Secondary outcomes (3)

  1. Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.

    After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.

    Measured: Up to 4 months

  2. Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.

    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.

    Measured: 3 months post study

  3. Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.

    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.

    Measured: 6 months post study

Timeline

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

  1. First posted20 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionNov 2008
  4. Study completionDec 2008

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00640042
Sponsor's protocol ID
K284-07-4001
Acronym
ACCESS 2008
Status last verified
Jun 2012
First submitted
13 Mar 2008
Last updated
11 Jun 2012
Data monitoring committee
No

Publications

  • The American Pain Foundation. Pain Facts & Figures. January 2007. Available from http://www.painfoundation.org/print.asp?file=Newsroom/PainFacts.htm.

  • Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.

  • Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1.

    PubMed 11029873

  • Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002 Apr;23(4):278-91. doi: 10.1016/s0885-3924(02)00383-4.

    PubMed 11997197

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing morphine sulfate extended release capsules in people with Pain, run by Pfizer at 384 sites in 2 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 384 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Feb 2010). 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?

Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) (time frame: Baseline (Week 0) to Visit 3 (Week 6)). The study lists 6 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 NCT00640042, which also lists 11 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 11 Jun 2012.

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