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An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA

NCT03661996 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 854

Last updated 2022-03-09

Study results available
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Summary

An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.

Conditions

Interventions

DRUG

CNTX-4975-05

Osteoarthritis (OA) intra-articular injection of CNTX-4975-05

DRUG

Lidocaine without epinephrine

15 mL lidocaine intra-articular injection

DEVICE

ElastoGel

Cooling Device

DEVICE

Breg Ice Water Pump

Cooling Device

Sponsors & Collaborators

  • Centrexion Therapeutics

    lead INDUSTRY

Principal Investigators

  • Randall M. Stevens, MD · Centrexion Therapeutics Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-10-22
Completion
2019-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03661996 on ClinicalTrials.gov