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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2009

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: 1
    • Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
  • Other: 2
    • Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Compare the tolerability of the two delivery methods measured by side effects.
    • Time Frame: 2 weeks after starting topical and oral ibuprofen

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Akron Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eloise Lemon, M.D. – Akron Children’s Hospital
  • Overall Official(s)
    • Emmanuel O Adekunle, M.D., Principal Investigator, Akron Children’s Hospital
    • Joseph Congeni, M.D., Study Director, Akron Children’s Hospital
    • Cynthia Bennett, MSN, CNP, Principal Investigator, Akron Children’s Hospital

References

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. doi: 10.1046/j.1365-2710.2002.00439.x.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.