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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Chronic Pain

In brief

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.

Key facts

Study ID

NCT00420992

Run by

Pfizer

People needed

547

Starts

2006-12-01

Expected to finish

2007-11-01

Last updated by the study team

2013-09-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Horizon Research Group — Mobile, Alabama, United States
• Arizona Center for Clinical Research — Peoria, Arizona, United States
• Arizona Research Center, Inc — Phoenix, Arizona, United States
• Premiere Pharmaceutical Research, LLC — Tempe, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Orange County Clinical Trials — Anaheim, California, United States
• STAT-CARE / Crest Clinical Trials — Anaheim, California, United States
• Southbay Pharma Research — Buena Park, California, United States
• Providence Clinical Res. (C-trials) — Burbank, California, United States
• Med Investigators Inc — Fair Oaks, California, United States
• Quality of Life Medical Center, LLC — Hawaiian Gardens, California, United States
• NervePro Research — Irvine, California, United States
• UCSD Pain and Palliative Care — La Jolla, California, United States
• USCD Pain and Palliative Care — La Jolla, California, United States
• Private Practice — Pico Rivera, California, United States
• Pain Institute of Santa Monica — Santa Monica, California, United States
• Boling Clinical Trials — Upland, California, United States
• Mountain View Clinical Research, Inc — Denver, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• New England Research Associates, LLC — Trumbull, Connecticut, United States
• MD Clinical — Hallandale, Florida, United States
• Eastern Research — Hialeah, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Drug Study Institiute — Jupiter, Florida, United States
• The Birmingham Pain Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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