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Topical Ibuprofen for Delayed Onset Mulscle Soreness

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NCT01794923

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19145 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01794923
Pfizer
Completed
Topical Ibuprofen for Delayed Onset Mulscle Soreness

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Topical Ibuprofen for Delayed Onset Mulscle Soreness
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01794923
B3491010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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