CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
CGS-200-1 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03528369
NCT03528369Phase 2Completed

A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)

Propella Therapeutics·interventional·Posted May 17, 2018·Updated Oct 30, 2024

In Brief

A Phase 2 clinical trial evaluating CGS-200-1, CGS-200-5, and 1 other intervention for Osteoarthritis, Knee and Pain. Completed, enrolled 122 participants across 6 sites.

Detailed Summary

This is a multi-center, randomized, double-blind clinical trial to examine the comparative effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content) (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied at the clinic for 60 minutes on each of four consecutive days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 17, 2018
Enrollment StartMay 14, 2018
Primary CompletionOct 14, 2018
Study CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.1 years ago

Interventions

CGS-200-1drug

CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.

CGS-200-5drug

CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.

CGS-200 Vehicledrug

CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.