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

Completed · Phase 4 · Has a placebo group

Conditions studied: Delayed Onset Muscle Soreness

In brief

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.

Key facts

Study ID

NCT02113566

Run by

Jean Brown Research

People needed

60

Starts

2013-02-01

Expected to finish

2013-05-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• are male or female, 18-55 years of age
• are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
• have a history of experiencing muscle soreness after moderately strenuous exercise
• are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
• are able to read, comprehend, and sign the informed consent form
• develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale

You may not qualify if…

• regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
• works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
• allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
• the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
• any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
• current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
• currently on chronic NSAID therapy for any reason
• current or recent history of drug or alcohol abuse
• has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
• has donated blood within the past 30 days
• is unable to swallow whole or large tablets or capsules
• is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
• participation in an investigational study within the past 30 days of screening
• prior participation in this trial
• site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.