Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study

PHASE3CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

October 24, 2019

Primary Completion Date

November 12, 2020

Study Completion Date

November 12, 2020

Conditions
Pain
Interventions
DRUG

Diclofenac diethylamine 2.32% gel

Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days.

DRUG

Diclofenac diethylamine 1.16% gel

Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 four times daily for 7 days.

OTHER

Placebo

Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days.

Trial Locations (14)

100730

GSK Investigational Site, Shenzhen

101200

GSK Investigational Site, Beijing

110044

GSK Investigational Site, Shenyang

116001

GSK Investigational Site, Dalian

200025

GSK Investigational Site, Shanghai

200080

GSK Investigational Site, Shanghai

200120

GSK Investigational Site, Shanghai

201449

GSK Investigational Site, Shanghai

423000

GSK Investigational Site, Chenzhou

510630

GSK Investigational Site, Guangzhou

518053

GSK Investigational Site, Shenzhen

650032

GSK Investigational Site, Kunming

710061

GSK Investigational Site, Xi'an

050051

GSK Investigational Site, Shijiazhuang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT04052620 - Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study | Biotech Hunter | Biotech Hunter