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

This study has been terminated.
(Study was not producing meaningful data.)
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00567528
First received: December 3, 2007
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  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 Injury
 Drug: Ibuprofen
Drug: ibuprofen

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 60
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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
  • opioid 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

Locations
United States, Ohio
Sports Medicine Department at Akron Children's Hospital
Akron, Ohio, United States, 44308
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:

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00567528     History of Changes
Other Study ID Numbers: IRB #0600210
Study First Received: December 3, 2007
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Soft tissue injuries
Topical ibuprofen
Adolescent athletes

Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013