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

NCT00567528 | Terminated

• 1 other identifier: IRB #0600210
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Soft Tissue Injury

Keywords

Soft tissue injuries; Topical ibuprofen; Adolescent athletes

Outcome Measures

Primary Outcomes (1)

• Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.

  10 days to 8 weeks after initial injury or flare up

Secondary Outcomes (1)

• Compare the tolerability of the two delivery methods measured by side effects.

  2 weeks after starting topical and oral ibuprofen

Study Arms (2)

1

OTHER

Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule

Drug: ibuprofen

2

OTHER

Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules

Drug: Ibuprofen

Interventions

ibuprofen DRUG

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.

2

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-19yo
• soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Sports Medicine Department at Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (1)

• 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. doi: 10.1046/j.1365-2710.2002.00439.x.

  PMID: 12472980 BACKGROUND

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Emmanuel O Adekunle, M.D.

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

• Joseph Congeni, M.D.

  Akron Children's Hospital

  STUDY DIRECTOR

• Cynthia Bennett, MSN, CNP

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: May 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 14, 2015

Record last verified: 2012-01

Locations

US (1)