A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

September 13, 2013 updated by: Pfizer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee

The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Study Type

Interventional

Enrollment (Actual)

547

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • The Birmingham Pain Center
      • Mobile, Alabama, United States, 36608
        • Horizon Research Group
    • Arizona
      • Peoria, Arizona, United States, 85383
        • Arizona Center For Clinical Research
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center, Inc
      • Tempe, Arizona, United States, 85282
        • Premiere Pharmaceutical Research, LLC
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Anaheim, California, United States, 92804
        • STAT-CARE / Crest Clinical Trials
      • Buena Park, California, United States, 90620
        • Southbay Pharma Research
      • Burbank, California, United States, 91505
        • Providence Clinical Res. (C-trials)
      • Fair Oaks, California, United States, 95628
        • Med Investigators Inc
      • Hawaiian Gardens, California, United States, 90716
        • Quality of Life Medical Center, LLC
      • Irvine, California, United States, 92618
        • NervePro Research
      • La Jolla, California, United States, 92093
        • UCSD Pain and Palliative Care
      • La Jolla, California, United States, 92093
        • USCD Pain and Palliative Care
      • Pico Rivera, California, United States, 90660
        • Private Practice
      • Santa Monica, California, United States, 90404
        • Pain Institute of Santa Monica
      • Upland, California, United States, 91786
        • Boling Clinical Trials
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research, Inc
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
      • Trumbull, Connecticut, United States, 06611
        • New England Research Associates, LLC
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Hialeah, Florida, United States, 33013
        • Eastern Research
      • Jacksonville, Florida, United States, 32257
        • Florida Institute of Medical Research
      • Jupiter, Florida, United States, 33458
        • Drug Study Institiute
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida
      • Merritt Island, Florida, United States, 32953
        • Pharmaceutical Research Associates Inc
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts - Pharmaceutical Research Center
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Weston, Florida, United States, 33331
        • Gold Coast Research LLC
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • River Birch Research Alliance
      • Decatur, Georgia, United States, 30034
        • Best Clinical Research
      • Marietta, Georgia, United States, 30066
        • Drug Studies America
      • Marietta, Georgia, United States, 30060
        • Non-Surgical Orthopaedic and Spine Center
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Research Associates of Central Illinois
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Newburgh, Indiana, United States, 47630
        • Welborn Clinic
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • International Clinical Research Institute, Inc
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, United States, 70114
        • Lousiana Research Associates Inc.
    • Maryland
      • Towson, Maryland, United States, 21286
        • Internal Research Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase III Clinical Research
      • No Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc
      • Springfield, Massachusetts, United States, 01107
        • FutureCare Studies
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical Education Alliance
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Medex Healthcare Research Inc
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Lovelace Scientific
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Partners in Primary Care
    • New York
      • Mount Vernon, New York, United States, 10550
        • Elkind Headache Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • The Arthritis Clinic and Carolina Bone and Joint
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Cincinnati, Ohio, United States, 45245
        • Community Research
      • Toledo, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research
      • Tulsa, Oklahoma, United States, 74101
        • Tulsa Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • LVH Neurosciences and Pain Research
      • Bensalem, Pennsylvania, United States, 19020
        • Pennsylvania Research Institute
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Fleetwood, Pennsylvania, United States, 19522
        • Commonwealth Primary Care / Fleetwood Clinical Research
      • Souderton, Pennsylvania, United States, 18964
        • Pivotal Clinical Research, Llc
      • Tipton, Pennsylvania, United States, 16684
        • Tipton Medical and Diagnostic Center
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Premier Medical Group
      • Cordova, Tennessee, United States, 38018
        • SCRI
      • Hendersonville, Tennessee, United States, 37075
        • Comprehensive Pain Specialists
      • Memphis, Tennessee, United States, 38119
        • SCRI
      • Milan, Tennessee, United States, 38358
        • Integrity Clinical Research, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Walter F. Chase, MD, PA
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Killeen, Texas, United States, 76543
        • Team Research of Central Texas
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, United States, 78218
        • North San Antonio Healthcare Associates
      • San Antonio, Texas, United States, 78217
        • Radiant Research, San Antonio Northeast
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • HypotheTest, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is 21 years of age or older
  • Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
  • Negative pregnancy test if female of childbearing potential
  • Subject is in general good health
  • Subject required treatment of joint pain within the last 90 days
  • Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
  • Subject is pregnant or breast-feeding
  • Subject is receiving systemic chemotherapy
  • Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
  • Subject has history of major depressive disorder not controlled with medication
  • Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
  • Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
  • Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALO-01
Up to 80 mg twice a day (bid)
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
capsules, up to 80 mg bid
Other Names:
  • Embeda
Placebo Comparator: Placebo
Twice a day (bid)
Drug: Placebo
capsules, bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Time Frame: randomization to 12 weeks following randomization
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
randomization to 12 weeks following randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: James B. Jones, MD, PharmD, Alpharma Pharmceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALO-KNT-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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