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Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00567528
Recruitment Status : Terminated (Study was not producing meaningful data.)
First Posted : December 5, 2007
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Eloise Lemon, Akron Children's Hospital

Tracking Information
First Submitted Date  ICMJE December 3, 2007
First Posted Date  ICMJE December 5, 2007
Last Update Posted Date January 14, 2015
Study Start Date  ICMJE May 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity. [ Time Frame: 10 days to 8 weeks after initial injury or flare up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00567528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2007)
Compare the tolerability of the two delivery methods measured by side effects. [ Time Frame: 2 weeks after starting topical and oral ibuprofen ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Official Title  ICMJE Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Brief Summary This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Soft Tissue Injury
Intervention  ICMJE
  • Drug: Ibuprofen
    Apply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
  • Drug: ibuprofen
    Apply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
Study Arms  ICMJE
  • 1
    Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
    Intervention: Drug: ibuprofen
  • 2
    Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules
    Intervention: Drug: Ibuprofen
Publications * Whitefield M, O'Kane CJ, Anderson S. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. J Clin Pharm Ther. 2002 Dec;27(6):409-17.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 1, 2011)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2007)
150
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 12-19yo
  • soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks

Exclusion Criteria:

  • Known hypersensitivity to aspirin or any NSAID,
  • allergy to eggs or egg products
  • history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
  • serious injury within six months
  • currently on anticoagulants
  • pregnant or lactating females
  • active arthritis in affected limb
  • open wounds, infected skin or fractures
  • opioid use within 7 days
  • severe psychological disorder
  • prior topical medication applied to the painful region/area of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00567528
Other Study ID Numbers  ICMJE IRB #0600210
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eloise Lemon, Akron Children's Hospital
Study Sponsor  ICMJE Akron Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel O Adekunle, M.D. Akron Children's Hospital
Study Director: Joseph Congeni, M.D. Akron Children's Hospital
Principal Investigator: Cynthia Bennett, MSN, CNP Akron Children's Hospital
PRS Account Akron Children's Hospital
Verification Date January 2012

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