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

Conditions:Neurology, Pain
Therapuetic Areas:Musculoskeletal, Neurology
Age Range:18 - 55
Start Date:February 2013
End Date:May 2013

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A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.

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.

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

- 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.
We found this trial at
1045 East 3900 South
Salt Lake City, Utah 84124
Salt Lake City, UT
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