A Safety and Effectiveness Study of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Pain Associated With Ankle Sprains.

Phase 4 Completed 260 enrolled Johnson & Johnson Consumer and Personal Products Worldwide

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains.

Timeline

Start: —
Primary completion: —
Completion: 2004-02

Outcome

Met primary endpoint

paper upper limit (3.26) of the 1-sided 95% confidence interval (CI) for the difference in least squares means did not exceed the noninferiority limit of 6.90. PMID 17052565 ↗

Publications

Results Dalton JD Jr, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006 Nov;48(5):615-23. doi: 10.1016/j.annemergmed.2006.05.015. Epub 2006 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	1300 mg	Oral

Indications

No indication recorded.