Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes - Full Text View

Sponsored by:	Akron Children's Hospital
Information provided by:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT00567528

Purpose

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

Condition	Intervention
Soft Tissue Injuries Comparison of Topical and Oral Ibuprofen	Drug: Ibuprofen Drug: ibuprofen

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the tolerability of the two delivery methods measured by side effects. [ Time Frame: 2 weeks after starting topical and oral ibuprofen ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1 Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule	Drug: ibuprofen 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.
2 Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules	Drug: Ibuprofen 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.

Eligibility

Ages Eligible for Study:	12 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567528

Contacts

Contact: Emmanuel O Adekunle, M.D.	330-543-2151	eadekunle@chmca.org
Contact: Cynthia Bennett, MSN, CNP	330-543-2103	cbennett@chmca.org

Locations

United States, Ohio
Sports Medicine Department at Akron Children's Hospital	Recruiting
Akron, Ohio, United States, 44308
Contact: Emmanuel O Adekunle, M.D. 330-543-2151 eadekunle@chmca.org
Principal Investigator: Emmanuel O Adekunle, M.D.
Sub-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

Sponsors and Collaborators

Akron Children's Hospital

Investigators

Principal Investigator:	Emmanuel O Adekunle, M.D.	Akron Children's Hospital
Study Director:	Joseph Congeni, M.D.	Akron Children's Hospital
Principal Investigator:	Cynthia Bennett, MSN, CNP	Akron Children's Hospital

More Information

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.

Responsible Party:	Akron Children's Hospital ( Emmanuel O Adekunle, M.D. )
Study ID Numbers:	IRB #0600210
Study First Received:	December 3, 2007
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00567528
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:

Soft tissue injuries
Topical ibuprofen
Adolesent athletes

Study placed in the following topic categories:

Ibuprofen
Soft Tissue Injuries
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009