Status:
COMPLETED
Ibuprofen Versus Placebo For Muscle Soreness
Lead Sponsor:
Jean Brown Research
Conditions:
Muscle Soreness
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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.
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 cu...
Eligibility Criteria
Inclusion
- Subjects must meet the following criteria to be included in the study:
- Male or female subjects aged 18-55 years;
- In good general health;
- Non-pregnant, non-lactating female subjects must be:
- physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
- 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.
- History of experiencing muscle pain/soreness after moderately strenuous exercise;
- Subjects are excluded from the study if any of the following criteria apply:
- Currently participating in an exercise regimen.
- Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
- History of rhabdomyolysis;
- Have participated in an investigational study within the past 30 days of screening;
- Are an employee or relative of an employee of the study site (directly involved with the study).
Exclusion
Key Trial Info
Start Date :
April 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03228992
Start Date
April 10 2017
End Date
July 31 2017
Last Update
August 4 2017
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124