Topical Ibuprofen for Delayed Onset Mulscle Soreness

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NCT01794923

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Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19145, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs

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Advanced Information
Descriptive Information
Brief Title  ICMJE Topical Ibuprofen for Delayed Onset Mulscle Soreness
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: IBU BID
    10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days
  • Drug: Placebo BID
    10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days
  • Drug: IBU TID
    10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days
  • Drug: Placebo TID
    10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
Study Arms  ICMJE
  • Experimental: Ibuprofen 5% topical gel BID
    IBU BID (Treatment A)
    Intervention: Drug: IBU BID
  • Placebo Comparator: Placebo topical gel BID
    Placebo BID (Treatment B)
    Intervention: Drug: Placebo BID
  • Experimental: Ibuprofen 5% topical gel TID
    IBU TID (Treatment C)
    Intervention: Drug: IBU TID
  • Placebo Comparator: Placebo topical gel TID
    Placebo TID (Treatment D)
    Intervention: Drug: Placebo TID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2014)		205
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2013)		222
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01794923
Other Study ID Numbers  ICMJE B3491010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP