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

NCT00420992 ↗

Phase 3 Completed 547 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-12
Primary completion: 2007-11
Completion: 2007-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); ALO-01 vs Placebo; p = 0.0445; ANCOVA; NCT00420992 ↗

Publications

Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Morphine	Other / unclassified	80 mg	—
Subject	Naltrexone	Small molecule	—	—