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Ibuprofen Versus Placebo For Muscle Soreness

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ClinicalTrials.gov Identifier: NCT03228992
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Derek Muse, Jean Brown Research

Brief Summary:
The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.

Condition or disease Intervention/treatment Phase
Muscle Soreness Drug: Ibuprofen 400 mg Other: Placebo Phase 4

Detailed Description:

This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.

The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 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, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen
Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
Drug: Ibuprofen 400 mg
Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.

Placebo Comparator: Placebo
Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
Other: Placebo
Subjects will receive 4 doses of placebo over a 24 hour period.




Primary Outcome Measures :
  1. Model Sensitivity [ Time Frame: 24 hours ]
    Assess whether ibuprofen provides more relief than placebo in the DOMS model.



Information from the National Library of Medicine

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

Subjects must meet the following criteria to be included in the study:

  1. Male or female subjects aged 18-55 years;
  2. In good general health;
  3. Non-pregnant, non-lactating female subjects must be:

    1. physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
    2. practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization.
  4. History of experiencing muscle pain/soreness after moderately strenuous exercise;

Subjects are excluded from the study if any of the following criteria apply:

  1. Currently participating in an exercise regimen.
  2. Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
  3. History of rhabdomyolysis;
  4. Have participated in an investigational study within the past 30 days of screening;
  5. Are an employee or relative of an employee of the study site (directly involved with the study).

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): NCT03228992


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Jean Brown Research

Additional Information:
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Responsible Party: Derek Muse, Principal Investigator, Jean Brown Research
ClinicalTrials.gov Identifier: NCT03228992     History of Changes
Other Study ID Numbers: JBR-002
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ibuprofen
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action