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. 2015 Jun 15;2015(6):CD007402. doi: 10.1002/14651858.CD007402.pub3

NCT02100670.

Trial name or title A clinical study to assess the efficacy and onset of pain relief of topical MFC51123 diclofenac‐menthol gel versus controls in ankle sprain
Methods R, DB, PC, and AC, parallel groups
Participants Acute lateral ankle sprain, Grade I or II, ≤ 24 hours, PI ≥ 5/10. Age 16 to 65 years
Estimated enrolment 400
Interventions Diclofenac sodium 1% + methanol 3% gel
 Diclofenac sodium 1% + methanol 0.09% gel
 Methanol 3% gel
 Placebo + 0.09% methanol gel
 Treatment for 10 days with 4 g gel x 4 daily
Outcomes PR
 PID on movement (0 to 10 days)
 PGE
 Time to complete recovery
Adverse events
Starting date November 2013
Contact information GSKClinicalSupportHD@gsk.com
Notes Estimated completion November 2014