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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Morphine; Naltrexone

Criteria

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