A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
- Conditions
- OsteoarthritisChronic 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
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALO-01 ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) Up to 80 mg twice a day (bid) Placebo Placebo Twice a day (bid)
- Primary Outcome Measures
Name Time Method 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
Name Time Method
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