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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-19
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2018-04-13
• Last updated: 2020-02-24
• Results posted: 2020-02-24

Locations

5 sites across 2 countries: Germany, United Kingdom