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.
Sprains and Strains, Pain
About this trial
This is an interventional treatment trial for Sprains and Strains focused on measuring ankle sprain, acetaminophen extended release, ibuprofen
Eligibility 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