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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261560
First Posted: December 5, 2005
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Consumer and Personal Products Worldwide
  Purpose
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.

Condition Intervention Phase
Sprains and Strains Pain Drug: acetaminophen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 260
Study Completion Date: February 2004
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 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261560


Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
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.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00261560     History of Changes
Other Study ID Numbers: CR002824
First Submitted: December 2, 2005
First Posted: December 5, 2005
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
ankle sprain
acetaminophen extended release, ibuprofen

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action