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

Phase 3
Completed
Conditions
Osteoarthritis
Chronic Pain
Interventions
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Drug: Placebo
Registration Number
NCT00420992
Lead Sponsor
Pfizer
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
547
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ALO-01ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)Up to 80 mg twice a day (bid)
PlaceboPlaceboTwice a day (bid)
Primary Outcome Measures
NameTimeMethod
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)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (79)

Advanced Biomedical Research of America

🇺🇸

Las Vegas, Nevada, United States

Community Research

🇺🇸

Cincinnati, Ohio, United States

International Clinical Research Institute, Inc

🇺🇸

Overland Park, Kansas, United States

UCSD Pain and Palliative Care

🇺🇸

La Jolla, California, United States

USCD Pain and Palliative Care

🇺🇸

La Jolla, California, United States

Quality of Life Medical Center, LLC

🇺🇸

Hawaiian Gardens, California, United States

Advanced Clinical Research Institute

🇺🇸

Anaheim, California, United States

Southbay Pharma Research

🇺🇸

Buena Park, California, United States

MD Clinical

🇺🇸

Hallandale Beach, Florida, United States

Med Investigators Inc

🇺🇸

Fair Oaks, California, United States

Horizon Research Group

🇺🇸

Mobile, Alabama, United States

NervePro Research

🇺🇸

Irvine, California, United States

Providence Clinical Res. (C-trials)

🇺🇸

Burbank, California, United States

STAT-CARE / Crest Clinical Trials

🇺🇸

Anaheim, California, United States

Orange County Clinical Trials

🇺🇸

Anaheim, California, United States

Stamford Therapeutics Consortium

🇺🇸

Stamford, Connecticut, United States

FPA Clinical Research

🇺🇸

Kissimmee, Florida, United States

Medex Healthcare Research Inc

🇺🇸

St. Louis, Missouri, United States

Pain Institute of Santa Monica

🇺🇸

Santa Monica, California, United States

Boling Clinical Trials

🇺🇸

Upland, California, United States

Drug Study Institiute

🇺🇸

Jupiter, Florida, United States

Elkind Headache Center

🇺🇸

Mount Vernon, New York, United States

Eastern Research

🇺🇸

Hialeah, Florida, United States

Northwest Clinical Trials

🇺🇸

Boise, Idaho, United States

Internal Research Center

🇺🇸

Towson, Maryland, United States

Best Clinical Research

🇺🇸

Decatur, Georgia, United States

Phase III Clinical Research

🇺🇸

Fall River, Massachusetts, United States

FutureCare Studies

🇺🇸

Springfield, Massachusetts, United States

Innovative Research of West Florida

🇺🇸

Largo, Florida, United States

Coastal Medical Research

🇺🇸

Port Orange, Florida, United States

HypotheTest, LLC

🇺🇸

Roanoke, Virginia, United States

The Birmingham Pain Center

🇺🇸

Birmingham, Alabama, United States

Arizona Research Center, Inc

🇺🇸

Phoenix, Arizona, United States

COR Clinical Research

🇺🇸

Oklahoma City, Oklahoma, United States

Mountain View Clinical Research, Inc

🇺🇸

Denver, Colorado, United States

Health Research Institute

🇺🇸

Oklahoma City, Oklahoma, United States

Cutting Edge Research

🇺🇸

Oklahoma City, Oklahoma, United States

Radiant Research, San Antonio Northeast

🇺🇸

San Antonio, Texas, United States

Progressive Clinical Research

🇺🇸

San Antonio, Texas, United States

Partners in Primary Care

🇺🇸

Voorhees, New Jersey, United States

Comprehensive Pain Specialists

🇺🇸

Hendersonville, Tennessee, United States

Private Practice

🇺🇸

Pico Rivera, California, United States

Florida Institute of Medical Research

🇺🇸

Jacksonville, Florida, United States

Pharmaceutical Research Associates Inc

🇺🇸

Merritt Island, Florida, United States

Gold Coast Research LLC

🇺🇸

Weston, Florida, United States

Research Associates of Central Illinois

🇺🇸

Peoria, Illinois, United States

Ormond Medical Arts - Pharmaceutical Research Center

🇺🇸

Ormond Beach, Florida, United States

MediSphere Medical Research Center, LLC

🇺🇸

Evansville, Indiana, United States

Non-Surgical Orthopaedic and Spine Center

🇺🇸

Marietta, Georgia, United States

University Clinical Research, Inc

🇺🇸

Pembroke Pines, Florida, United States

River Birch Research Alliance

🇺🇸

Blue Ridge, Georgia, United States

Welborn Clinic

🇺🇸

Newburgh, Indiana, United States

Clinical Research Source, Inc

🇺🇸

Toledo, Ohio, United States

Drug Studies America

🇺🇸

Marietta, Georgia, United States

New England Research Associates, LLC

🇺🇸

Trumbull, Connecticut, United States

The Arthritis Clinic and Carolina Bone and Joint

🇺🇸

Charlotte, North Carolina, United States

Tulsa Clinical Research

🇺🇸

Tulsa, Oklahoma, United States

LVH Neurosciences and Pain Research

🇺🇸

Allentown, Pennsylvania, United States

Commonwealth Primary Care / Fleetwood Clinical Research

🇺🇸

Fleetwood, Pennsylvania, United States

Pennsylvania Research Institute

🇺🇸

Bensalem, Pennsylvania, United States

Altoona Center for Clinical Research

🇺🇸

Duncansville, Pennsylvania, United States

Pivotal Clinical Research, LLC

🇺🇸

Souderton, Pennsylvania, United States

Tipton Medical and Diagnostic Center

🇺🇸

Tipton, Pennsylvania, United States

Premier Medical Group

🇺🇸

Clarksville, Tennessee, United States

SCRI

🇺🇸

Memphis, Tennessee, United States

North San Antonio Healthcare Associates

🇺🇸

San Antonio, Texas, United States

Integrity Clinical Research, LLC

🇺🇸

Milan, Tennessee, United States

Walter F. Chase, MD, PA

🇺🇸

Austin, Texas, United States

InSite Clinical Research

🇺🇸

DeSoto, Texas, United States

Team Research of Central Texas

🇺🇸

Killeen, Texas, United States

Arizona Center for Clinical Research

🇺🇸

Peoria, Arizona, United States

Clinical Trials Management, LLC

🇺🇸

Mandeville, Louisiana, United States

Northeast Medical Research Associates, Inc

🇺🇸

No Dartmouth, Massachusetts, United States

Synergy Medical Education Alliance

🇺🇸

Saginaw, Michigan, United States

Premiere Pharmaceutical Research, LLC

🇺🇸

Tempe, Arizona, United States

Lovelace Scientific

🇺🇸

Henderson, Nevada, United States

Stedman Clinical Trials

🇺🇸

Tampa, Florida, United States

Lousiana Research Associates Inc.

🇺🇸

New Orleans, Louisiana, United States

The Center for Clinical Research, LLC

🇺🇸

Winston-Salem, North Carolina, United States

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