Official Title: “Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes”

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: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

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
    Safety Issue?: No

Secondary Measures

• Compare the tolerability of the two delivery methods measured by side effects.
  • Time Frame: 2 weeks after starting topical and oral ibuprofen
    Safety Issue?: No

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
• opiod use within 7 days
• severe psychological disorder
• prior topical medication applied to the painful region/area of study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Akron Children's Hospital

Overall Clinical Trial Officials and Contacts

Emmanuel O Adekunle, M.D. Principal Investigator Akron Children's Hospital  

Overall Contact: Emmanuel O Adekunle, M.D. 330-543-2151 eadekunle@chmca.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567528

Study ID Number: IRB #0600210

ClinicalTrials.gov Identifier: NCT00567528

Health Authority: United States: Institutional Review Board