Topical Ibuprofen for Delayed Onset Mulscle Soreness
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: IBU BID (Drug); Placebo BID (Drug); IBU TID (Drug); Placebo TID (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical
Gel versus placebo administered two or three times daily for the treatment of pain
associated with delayed onset muscle soreness following intense eccentric exercise of the
elbow flexor muscles.
Clinical Details
Official title: Placebo-controlled, Double-blind Evaluation of the Efficacy and Safety of Ibuprofen 5% Topical Gel for the Treatment of Delayed-onset Muscle Soreness of the Elbow Flexor Muscles
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Muscle Soreness with Movement (change from baseline) over 0-24 hours post Dose 1
Secondary outcome: Change from baseline in the time weighted sum of muscle soreness with movementChange from baseline in the time weighted sum of spontaneous muscle soreness Time weighted sum of muscle soreness relief Change from baseline in muscle stiffness Subject Global Assessment of Medication Number of doses of rescue medication Percentage of subjects taking rescue medication Time to rescue medication following each dose
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness
activities for a minimum of 3 months prior to entry in the study; subjects must be willing
to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice,
massage) and other forms of soreness relief during the study
Exclusion Criteria:
Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs
Locations and Contacts
Pfizer Investigational Site, Philadelphia, Pennsylvania 19145, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2013
Last updated: April 11, 2014
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