CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Etoricoxib 75 mg 4% DMSO Gel +7 moredrug
Likely dose
Etoricoxib 75 mg 4% DMSO Gelfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01980940
NCT01980940Phase 2Completed
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A Study to Assess the Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Osteoarthritis Patients

Organon and Co·interventional·Posted Nov 11, 2013·Updated Jun 27, 2024

In Brief

A Phase 2 clinical trial evaluating Etoricoxib 75 mg 4% DMSO Gel, Etoricoxib 75 mg 4% PG Gel, and 6 other interventions for Osteoarthritis Pain. Completed, enrolled 70 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis Pain
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 11, 2013
Enrollment StartDec 23, 2013
Primary CompletionNov 26, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.6 years ago

Interventions

Etoricoxib 75 mg 4% DMSO Geldrug

Etoricoxib 75 mg 4% DMSO gel applied topically.

Etoricoxib 75 mg 4% PG Geldrug

Etoricoxib 75 4% PG gel applied topically.

Etoricoxib 150 mg 4% DMSO Geldrug

Etoricoxib 150 mg 4% DMSO gel applied topically.

Etoricoxib 150 mg 4% PG Geldrug

Etoricoxib 150 mg 4% PG gel applied topically.

Etoricoxib 163 mg 4% DMSO geldrug

Etoricoxib 163 mg 4% DMSO gel applied topically

Placebodrug

Placebo gel applied topically.

Etoricoxib 50 mg 4% DMSOdrug

Etoricoxib 50 mg 4% DMSO gel applied topically.

Matching Placebo to Etoricoxib 50 mg 4% DMSO Geldrug

Matching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically.