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Sponsored by: |
Akron Children's Hospital |
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Information provided by: | Akron Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00567528 |
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 |
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Soft Tissue Injuries Comparison of Topical and Oral Ibuprofen |
Drug: Ibuprofen Drug: ibuprofen |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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1
Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
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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.
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2
Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules
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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.
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Ages Eligible for Study: | 12 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emmanuel O Adekunle, M.D. | 330-543-2151 | eadekunle@chmca.org |
Contact: Cynthia Bennett, MSN, CNP | 330-543-2103 | cbennett@chmca.org |
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 |
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 |
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 |
Soft tissue injuries Topical ibuprofen Adolesent athletes |
Ibuprofen Soft Tissue Injuries Wounds and Injuries Disorders of Environmental Origin |
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 |