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