GRACE - 208901 - Phase 1 study
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Steady-State Pharmacokinetic and Disposition Study Characterizing Diclofenac’s Plasma and Knee Exposure in Osteoarthritis Subjects Undergoing Scheduled Arthroplasty after Treatment with Diclofenac Diethylamine 2.32% Gel
IRAS ID
242407
Contact name
Prof Hemant Pandit
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-000218-40
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
This is a randomised, double-blind, multi-centre, placebo-controlled clinical study investigating the concentration of topically applied diclofenac achieved in the plasma and knee joint synovial tissue and synovial fluid following twice daily dosing for seven days.
The study will be performed in patients diagnosed with osteoarthritis (OA) of the knee who are scheduled for single knee replacement as a treatment for their OA.
The 2.32% diclofenac diethylamine (DDEA) gel (Voltarol 12 hour Emulgel), which is available over the counter, contains a non-steroidal anti-inflammatory drug (NSAID) called diclofenac. Diclofenac works to prevent the production of prostaglandins, hormone-like substances in the body that cause pain and inflammation.
By reducing their effects, diclofenac helps to relieve pain and reduce inflammation. Voltarol 12 hour Emulgel is approved for the local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscle and joints e.g. due to strains and bruises, localised forms of soft tissue rheumatism.
Patients will be randomised in a 2:1 ratio: two thirds will receive DDEA 2.32% gel treatment and one third placebo gel.
Study procedures include medical history, physical examination, vital signs, blood and urine sample collection, tissue and fluid samples from the scheduled knee surgery.
GlaxoSmithKline Consumer Healthcare is sponsoring this trial and it is expected that approximately 50 male & female patients will take part from the UK & Germany. The study is expected to last 3 months.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0143
Date of REC Opinion
19 Apr 2018
REC opinion
Further Information Favourable Opinion