MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
Phase 3
Completed
- Conditions
- Ankle Sprains
- Interventions
- Registration Number
- NCT01198834
- Lead Sponsor
- MEDRx USA, Inc.
- Brief Summary
A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description MRX-7EAT Patch MRX-7EAT Treatment with MRX-7EAT Patch Placebo Patch Placebo Treatment with Placebo Patch Lidocaine Patch Lidocaine Treatment with Lidocaine Patch Etodolac Patch Etodolac Treatment with Etodolac Patch
- Primary Outcome Measures
Name Time Method Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS). Days 2 to 7
- Secondary Outcome Measures
Name Time Method Time to Pain Resolution Days 1 to 7 Impact on Physical Function Days 1 to 7 Current Pain Intensity during Point and Flex Days 1 through 7 Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot Each Clinical Visit Assessment of Patch Adherence Clinical Visit 2 Subject's Treatment Satisfaction Clinical Visit 3 Total Number of Patches Used Days 1 to 7