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:
Information provided by:
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00261560
First received: December 2, 2005
Last updated: June 28, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 2, 2005
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014