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

Primary Purpose

Soft Tissue Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
ibuprofen
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Injury focused on measuring Soft tissue injuries, Topical ibuprofen, Adolescent athletes

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Sports Medicine Department at Akron Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2007
Last Updated
January 13, 2015
Sponsor
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00567528
Brief Title
Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Official Title
Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Study was not producing meaningful data.
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injury
Keywords
Soft tissue injuries, Topical ibuprofen, Adolescent athletes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
Arm Title
2
Arm Type
Other
Arm Description
Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
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
Intervention Name(s)
ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Compare the tolerability of the two delivery methods measured by side effects.
Time Frame
2 weeks after starting topical and oral ibuprofen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel O Adekunle, M.D.
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Congeni, M.D.
Organizational Affiliation
Akron Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cynthia Bennett, MSN, CNP
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine Department at Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12472980
Citation
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.
Results Reference
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Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

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