Status:
COMPLETED
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.
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Sprains and Strains
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The objective of this randomized, double-blind, parallel-group study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00261560
End Date
February 1 2004
Last Update
June 29 2011
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