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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jean Brown Research
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.