A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain

PHASE3CompletedINTERVENTIONAL
Enrollment

385

Participants

Timeline

Start Date

November 1, 2013

Primary Completion Date

March 1, 2015

Study Completion Date

March 22, 2015

Conditions
Pain
Interventions
DRUG

1% diclofenac sodium plus 3% menthol

To be applied four times daily for 10 days.

DRUG

1% diclofenac sodium plus 0.09% menthol

To be applied four times daily for 10 days.

DRUG

3% menthol

To be applied four times daily for 10 days.

DRUG

Placebo with 0.09% menthol gel

To be applied four times daily for 10 days.

Trial Locations (3)

24119

pro scientia med im MARE Klinikum, Kiel

D-14050

PAREXEL International - Sites in Germany, Berlin

PAREXEL International, LLC, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY