Ibuprofen Versus Placebo For Muscle Soreness
- Registration Number
- NCT03228992
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibuprofen Ibuprofen 400 mg Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period. Placebo Placebo Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
- Primary Outcome Measures
Name Time Method Model Sensitivity 24 hours Assess whether ibuprofen provides more relief than placebo in the DOMS model.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States