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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.

Primary Purpose

Sprains and Strains, Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
acetaminophen
Sponsored by
Johnson & Johnson Consumer and Personal Products Worldwide
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprains and Strains focused on measuring ankle sprain, acetaminophen extended release, ibuprofen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    December 2, 2005
    Last Updated
    June 28, 2011
    Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00261560
    Brief Title
    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.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Consumer and Personal Products Worldwide

    4. Oversight

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sprains and Strains, Pain
    Keywords
    ankle sprain, acetaminophen extended release, ibuprofen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    260 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    acetaminophen
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17052565
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    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.

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