A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
CompletedPhase 3NCT00420992
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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
- Conditions
- Interventions
- Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
- Drug: Placebo
- Sponsor
- Pfizer
- Start date
- 2006-12
- Primary completion
- 2007-11
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 81
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00420992