Clincosm LogoSign in Get a demo

DOMS: A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

Sponsor
Jean Brown Research (Other)
Overall Status
Completed
CT.gov ID
NCT02113566
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
2.9
Duration (Months)
20.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetaminophen 1000mg
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.

Drug: Acetaminophen 1000mg
Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
Other Names:
  • Tylenol

    		•
    Active Comparator: Ibuprofen

    2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.

    Drug: Acetaminophen 1000mg
    Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
    Other Names:
  • Tylenol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SPID (Sum Pain Intensity Difference) [0-48 hours]

      The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)

    Secondary Outcome Measures

    1. spontaneous muscle pain/soreness [0-48 hours]

    2. Muscle stiffness with movement [0-48 hours]

    3. Overall evaluation measures [0-48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • are male or female, 18-55 years of age

    • are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation

    • have a history of experiencing muscle soreness after moderately strenuous exercise

    • are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen

    • are able to read, comprehend, and sign the informed consent form

    • develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale

    Exclusion Criteria:

    • regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months

    • works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)

    • allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen

    • the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'

    • any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female

    • current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic

    • currently on chronic NSAID therapy for any reason

    • current or recent history of drug or alcohol abuse

    • has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment

    • has donated blood within the past 30 days

    • is unable to swallow whole or large tablets or capsules

    • is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.

    • participation in an investigational study within the past 30 days of screening

    • prior participation in this trial

    • site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jean Brown Research Salt Lake City Utah United States 84124

    Sponsors and Collaborators

    • Jean Brown Research

    Investigators

    • Principal Investigator: Derek Muse, MD, Jean Brown Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Derek Muse, Derek Muse, MD, Jean Brown Research
    ClinicalTrials.gov Identifier:
    NCT02113566
    Other Study ID Numbers:
    • JBR-001
    First Posted:
    Apr 14, 2014
    Last Update Posted:
    Dec 2, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Derek Muse, Derek Muse, MD, Jean Brown Research
    Delayed onset muscle soreness
    DOMS
    Additional relevant MeSH terms:
    Myalgia
    Acetaminophen

    Study Results

    No Results Posted as of Dec 2, 2015