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TerminatedNCT00567528Updated Jan 14, 2015

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

An interventional study of Ibuprofen and ibuprofen in Soft Tissue Injury, sponsored by Akron Children's Hospital. Terminated at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by Akron Children's Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Study was not producing meaningful data.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Study 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

02

Conditions studied

  • Soft Tissue Injury

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Keywords

  • Soft tissue injuries
  • Topical ibuprofen
  • Adolescent athletes
03

In context

Soft Tissue Injuries

63 studies on the registry are indexed under Soft Tissue Injuries; 8 are open to participants now.

This study's enrollment of 60 is close to the median of 65 across 50 interventional studies indexed under Soft Tissue Injuries.

Browse Soft Tissue Injuries studies →

Lead sponsor

Akron Children's Hospital is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 12-19yo
  • soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Other
    1

    Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

    Drug: ibuprofen

  • Other
    2

    Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

    Drug: Ibuprofen

Interventions

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.

    Time frame: 10 days to 8 weeks after initial injury or flare up

Secondary outcomes

  1. Compare the tolerability of the two delivery methods measured by side effects.

    Time frame: 2 weeks after starting topical and oral ibuprofen

07

Study locations

1 site
  • Sports Medicine Department at Akron Children's Hospital
    Akron, Ohio 44308, United States
08

References and documents

Publications

  • Whitefield M, O'Kane CJ, Anderson S. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. J Clin Pharm Ther. 2002 Dec;27(6):409-17. doi: 10.1046/j.1365-2710.2002.00439.x. PubMed 12472980 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00567528
Lead sponsor
Akron Children's Hospital
Responsible party
Eloise Lemon (M.D., Akron Children's Hospital) — Principal investigator
First posted
Dec 5, 2007
Start date
May 2006
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Jan 14, 2015

Study contacts

Emmanuel O Adekunle, M.D.
principal investigator · Akron Children's Hospital
Joseph Congeni, M.D.
study director · Akron Children's Hospital
Cynthia Bennett, MSN, CNP
principal investigator · Akron Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ibuprofen

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