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

Not Applicable

Terminated

• Conditions: Soft Tissue Injury
• Interventions: Drug: ibuprofen

• Registration Number: NCT00567528
• Lead Sponsor: Akron Children's Hospital

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 available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2012-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ibuprofen	Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
2	ibuprofen	Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sports Medicine Department at Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States