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

Pain Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Steady-State Pharmacokinetic and Disposition Study Characterizing Diclofenac's Plasma and Knee Exposure in Osteoarthritis (OA) Subjects Undergoing Scheduled Arthroplasty After Treatment With Diclofenac Diethylamine (DDEA) 2.32% Gel

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the knee joint following topical administration of DDEA gel 4 gram (g) applied twice daily for 7 days.

Clinical Trial Description

The study will be performed in Participants diagnosed with OA of the knee who are scheduled for arthroplasty of the knee as a treatment for their OA.

Approximately fifty (50) male and female OA participants, who, at the time of screening, are ≥50 years old, will be randomized in a 2:1 ratio: two thirds will receive DDEA gel treatment and one third placebo gel.After providing informed consent to participate in the study the participants will need to forego any non-steroidal anti inflammatory drug (NSAID) or cyclooxygenase (COX)-2 treatment for at least 7 days prior to starting study treatment (Visit 2) to allow wash-out of existing therapy and thus avoiding confounding the effect of the study treatments.

There will be 4 study center visits as follows:

Visit 1 Screening visit: Day -7 (Window: Day-10 to Day-7) Visit 2 Baseline (randomization) visit: Morning of Day 1 Visit 3 Hospital admittance through to surgery and post-surgery: Evening of Day 7 through Day 8 (Surgery may be delayed by up to 7 days) Visit 4 Final visit: Day 8 to Day 10 (Between recovery and discharge)

The Participants will be provided paracetamol as rescue medication, to be used up to a total daily dose of 4 gram (g). Rescue medication will be available from the Screening Visit (Day -7) through to end of Day 7. Should the need arise for additional pain relief, the investigators will be allowed to prescribe codeine or tramadol. Postoperative analgesia will be handled according to the surgical center's pain management procedures. ;

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

• NCT number: NCT03497039
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2018
• Completion date: March 1, 2019