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A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

NCT03429049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2022-07-26

Study results available
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Summary

This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

CNTX-4975-05

Receiving CNTX-4975-05 injection

DRUG

Placebo

Receiving Placebo injection

Sponsors & Collaborators

  • Centrexion Therapeutics

    lead INDUSTRY

Principal Investigators

  • Randall M. Stevens, MD · Centrexion Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2019-11-22
Completion
2019-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT03429049 on ClinicalTrials.gov