MedTrace Logo

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

NCT01980940 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-06-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Osteoarthritis Pain

Interventions

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.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-23
Primary Completion
2014-11-26
Completion
2014-11-26

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980940 on ClinicalTrials.gov