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.
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.
1 other identifier
interventional
260
0 countries
N/A
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 for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedJune 29, 2011
June 1, 2011
December 2, 2005
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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. doi: 10.1016/j.annemergmed.2006.05.015. Epub 2006 Sep 1.
PMID: 17052565RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 5, 2005
Study Completion
February 1, 2004
Last Updated
June 29, 2011
Record last verified: 2011-06