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Study was not producing meaningful data.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule |
|
| 2 | Other | Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the tolerability of the two delivery methods measured by side effects. | 2 weeks after starting topical and oral ibuprofen |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine Department at Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12472980 | Background | 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. |
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| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| ibuprofen | Drug | 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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