NCT03661996

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 854 (actual)
• Sponsor: Centrexion Therapeutics · Industry
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-10-22
• Completion: 2019-10-22
• First posted: 2018-09-07
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study