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.

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 4

Conditions

Sprains and Strains

Pain

Treatments

Drug: acetaminophen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261560

CR002824

Details and patient eligibility

About

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.

Full 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 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. The primary efficacy endpoint is the change from baseline (Day 1) to Day 4 in the subjects' pain upon walking. Safety assessments consist of the monitoring of adverse events and assessments of the ankle injury during the course of the study. Two hypotheses are examined using a step down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with (Grade I or Grade II) lateral ankle sprains. If acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains, the second hypothesis is that acetaminophen extended release is superior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for nine days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for nine days

Enrollment

260 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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