NCT03228992

Ibuprofen Versus Placebo For Muscle Soreness

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Jean Brown Research · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Muscle Soreness

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg	Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.
OTHER	Placebo	Subjects will receive 4 doses of placebo over a 24 hour period.

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-07-25
• Last updated: 2017-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study