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.

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group Study Comparing the Safety and Effectiveness of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Ankle Sprains.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261560
• Other study ID #: CR002824
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: June 28, 2011
• Est. completion date: February 2004

Study information

• Verified date: June 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Sprains and Strains

Intervention

Drug:
• acetaminophen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

References & Publications (1)

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. Epub 2006 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (Day 1) to Day 4 in the subject's pain upon walking using a 0 to 100 mm visual analogue scale.
Secondary	Change from baseline to Day 9 in pain upon walking; change from baseline to Day 4 and 9 in: ability to walk, ankle swelling, ankle bruising, and ankle's range of motion; overall satisfaction with treatment from Day 1 to Day 4 and Day 1 to Day 9.