drugset / Trial / NCT00240799
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.
Phase 3
Completed
542 enrolled
Johnson & Johnson Consumer and Personal Products Worldwide
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2004-10
Outcome
Mixed primary results
paper WOMAC physical function subscale score was significantly greater for acetaminophen ER than for placebo (P = 0.011) PMID 25121804 ↗
paper patient's global assessment of response to therapy was significantly greater for acetaminophen ER than for placebo (P = 0.010) PMID 25121804 ↗
paper WOMAC pain subscale score was marginally greater for acetaminophen ER than for placebo (P = 0.054) PMID 25121804 ↗
Publications
- Prior MJ, Harrison DD, Frustaci ME. A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis. Curr Med Res Opin. 2014 Nov;30(11):2377-87. doi: 10.1185/03007995.2014.949646. Epub 2014 Aug 14.
- Kuffner EK, Temple AR, Cooper KM, Baggish JS, Parenti DL. Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials. Curr Med Res Opin. 2006 Nov;22(11):2137-48. doi: 10.1185/030079906x148346.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1300 mg | Oral |