Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Information source: Akron Children's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Soft Tissue Injuries; Comparison of Topical and Oral Ibuprofen
Intervention: Ibuprofen (Drug); ibuprofen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Akron Children's Hospital Official(s) and/or principal investigator(s):
Emmanuel O Adekunle, M.D., Principal Investigator, Affiliation: Akron Children's Hospital
Joseph Congeni, M.D., Study Director, Affiliation: Akron Children's Hospital
Cynthia Bennett, MSN, CNP, Principal Investigator, Affiliation: Akron Children's Hospital
Overall contact:
Emmanuel O Adekunle, M.D., Phone: 330-543-2151, Email: eadekunle@chmca.org
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
Clinical Details
Official title: Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
Secondary outcome: Compare the tolerability of the two delivery methods measured by side effects.
Eligibility
Minimum age: 12 Years.
Maximum age: 19 Years.
Gender(s): Both.
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
- opiod use within 7 days
- severe psychological disorder
- prior topical medication applied to the painful region/area of study
Locations and Contacts
Emmanuel O Adekunle, M.D., Phone: 330-543-2151, Email: eadekunle@chmca.org
Sports Medicine Department at Akron Children's Hospital, Akron, Ohio 44308, United States; Recruiting
Emmanuel O Adekunle, M.D., Phone: 330-543-2151, Email: eadekunle@chmca.org
Emmanuel O Adekunle, M.D., Principal Investigator
Cynthia Bennett, MSN, CNP, Sub-Investigator
Joseph Congeni, MD, Sub-Investigator
Keith Loud, MD, Sub-Investigator
Troy Smurawa, MD, Sub-Investigator
Amy Standford, MSN, CNP, Sub-Investigator
Julie Kerr, MD, Sub-Investigator
Additional Information
Related 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.
Starting date: May 2006
Ending date: January 2009
Last updated: December 6, 2007
|
