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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 movement

Change 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

Page last updated: August 23, 2015

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