Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee

Phase 2 Terminated 241 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

Timeline

Start: 2009-03
Primary completion: 2009-07
Completion: 2009-07

Outcome

Missed primary endpoint

Stopped: “The study was terminated after the planned interim analysis.”

paper AZD1386 showed no significant pain decrease based on the primary variable. PMID 24394343 ↗

Publications

Miller F, Bjornsson M, Svensson O, Karlsten R. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):189-99. doi: 10.1016/j.cct.2013.12.007. Epub 2014 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD1386	Small molecule	30 mg	Oral
Subject	AZD1386	Small molecule	90 mg	Oral

Indications

No indication recorded.