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

Soft Tissue Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00567528
• Other study ID #: IRB #0600210
• Status: Terminated
• Phase: N/A
• First received: December 3, 2007
• Last updated: January 13, 2015
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: January 2012
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Soft Tissue Injuries
• Soft Tissue Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sports Medicine Department at Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.		10 days to 8 weeks after initial injury or flare up	No
Secondary	Compare the tolerability of the two delivery methods measured by side effects.		2 weeks after starting topical and oral ibuprofen	No