NCT02113566

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

A Double-Blind, Repeat-Dose, Parallel Group 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: 60 (actual)
• Sponsor: Jean Brown Research · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Delayed Onset Muscle Soreness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2014-04-14
• Last updated: 2015-12-02

Locations

1 site across 1 country: United States