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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014