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
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
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
NCT ID
NCT00567528
First Posted
December 3, 2007
Last Updated
January 13, 2015
Sponsor
Akron Children's Hospital
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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