A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 19, 2018

Primary Completion Date

March 1, 2019

Study Completion Date

March 1, 2019

Conditions
Pain
Interventions
DRUG

Diclofenac Diethylamine (DDEA) gel

Diclofenac Diethylamine (DDEA) gel consists of 2.32% DDEA. DDEA gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of study treatment will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery.If surgery is delayed by up to 7 days dosing with DDEA gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study.

OTHER

Placebo gel

Placebo gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of placebo gel will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery. If surgery is delayed by up to 7 days dosing with placebo gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study.

Trial Locations (5)

97074

GSK Investigational Site, Würzburg

Unknown

GSK Investigational Site, Cambridge

G4 0SF

GSK Investigational Site, Glasgow

G81 4DY

GSK Investigational Site, Clydebank

LS7 4SA

GSK Investigational Site, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03497039 - A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty | Biotech Hunter | Biotech Hunter