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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567528

Enrollment

Registered

2007-12-05

Start date

2006-05-31

Completion date

2009-04-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Injury

Keywords

Soft tissue injuries, Topical ibuprofen, Adolescent athletes

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

Interventions

DRUGIbuprofen

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.

DRUGibuprofen

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 19 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026