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

Sponsor

Akron Children's Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00567528

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Injury	Drug: Ibuprofen Drug: ibuprofen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule	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.
Other: 2 Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules	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.

Arm

Intervention/Treatment

Other: 1

Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

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.

Other: 2

Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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