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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Soft Tissue Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

Group Type OTHER

ibuprofen

Intervention Type DRUG

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.

2

Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Group Type OTHER

Ibuprofen

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No