NCT01980940

The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168)

A Study to Assess the Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Osteoarthritis Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Study Part 1 is designed to assess the plasma pharmacokinetics of etoricoxib (ETOR) 4% dimethyl sulfoxide (DMSO) and propylene glycol (PG) formulations, each at 2 different doses, upon single-dose topical administration on the knee of osteoarthritis participants. Study Part 2 is designed to evaluate the efficacy of topical etoricoxib vs. placebo in the treatment of osteoarthritis of the knee. The primary hypothesis is that topical etoricoxib will be more effective than placebo in the treatment of osteoarthritis of the knee over 2 weeks of treatment as assessed by time-weighted average change from baseline on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analogue (VA) 3.0 pain subscale.

Detailed description

Part I of the study will consist of a single-dose, open-label, randomized, four-way cross over study with topical administration of etoricoxib gel on the knee of osteoarthritis participants. The washout between successive dose administrations will be at least one week. Part 2 of the study will consist of double-blind, randomized, placebo-controlled, parallel groups, multiple dose, twice daily topical administration of etoricoxib or placebo gel on the knee of osteoarthritis participants for a period of two weeks.

Conditions

• Osteoarthritis Pain

Interventions

Type	Name	Description
DRUG	Etoricoxib 75 mg 4% DMSO Gel	Etoricoxib 75 mg 4% DMSO gel applied topically.
DRUG	Etoricoxib 75 mg 4% PG Gel	Etoricoxib 75 4% PG gel applied topically.
DRUG	Etoricoxib 150 mg 4% DMSO Gel	Etoricoxib 150 mg 4% DMSO gel applied topically.
DRUG	Etoricoxib 150 mg 4% PG Gel	Etoricoxib 150 mg 4% PG gel applied topically.
DRUG	Etoricoxib 163 mg 4% DMSO gel	Etoricoxib 163 mg 4% DMSO gel applied topically
DRUG	Placebo	Placebo gel applied topically.
DRUG	Etoricoxib 50 mg 4% DMSO	Etoricoxib 50 mg 4% DMSO gel applied topically.
DRUG	Matching Placebo to Etoricoxib 50 mg 4% DMSO Gel	Matching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically.

Timeline

• Start date: 2013-12-23
• Primary completion: 2014-11-26
• Completion: 2014-11-26
• First posted: 2013-11-11
• Last updated: 2024-06-27
• Results posted: 2015-12-11