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.

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Have had an ankle sprain within 24 hours of study entry

• have ankle pain when walking

• have not recently used non-steroidal, anti-inflammatory drugs (NSAIDs), other pain relieving medications (including acetaminophen) or medicines that could interfere with the assessment of effectiveness

• if female, must not be pregnant or breastfeeding

Exclusion Criteria:

• Ankle sprain was the second ankle sprain within six months

• Both ankles were sprained

• Ankle sprain occurred on the same side of the body as a knee injury

• Ankle injury requires bed rest, hospitalization, surgical intervention, or use of a non-removable rigid cylindrical cast

• Subject reports severe or very severe pain at rest on a five-point scale of none, mild, moderate, severe or very severe