A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)

Phase 1 Completed 22 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindDiagnostic

Summary

This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.

Timeline

Start: 2008-06
Primary completion: 2008-11
Completion: 2008-11

Outcome

Mixed primary results

paper Compared with placebo, the TWA change from baseline PI on Day 3 was significantly better with tramadol/acetaminophen (P=0.043) but not with naproxen (P=0.089). PMID 20175977 ↗

Publications

Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	325 mg	—
Subject	Naproxen	Small molecule	500 mg	—
Subject	Tramadol	Other / unclassified	37.5 mg	—