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

Akron Children's Hospital

Status: Terminated

Conditions: Soft Tissue Injury

Treatments: Drug: Ibuprofen; Drug: ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00567528

IRB #0600210

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

1

Other group

Description:

Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

Treatment:

Drug: ibuprofen

2

Other group

Description:

Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Treatment:

Drug: Ibuprofen