An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
Recruiting at27 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Centrexion Therapeutics
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
RM
Randall M. Stevens, MD
Principal Investigator
Centrexion Therapeutics Corp
Eligibility Criteria
Inclusion Criteria
Male or female subjects between 40 and 95 years of age (inclusive)
Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using standard standing films (scored by the investigator) or using the fixed flexion method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.
Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
See 5 more
Treatment Details
Interventions
- Breg Ice Water Pump (Device)
- CNTX-4975-05 (Neurotoxin)
- ElastoGel (Device)
- Lidocaine without epinephrine (Local Anesthetic)
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Single Needle Injection Gel Pack Cooling Group - 2% LidocaineExperimental Treatment3 Interventions
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Group II: Single Needle Injection Gel Pack Cooling Group - 1% LidocaineExperimental Treatment3 Interventions
Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Group III: Shortened Gel Pack Cooling GroupExperimental Treatment3 Interventions
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Group IV: Gel Pack Cooling GroupExperimental Treatment3 Interventions
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Group V: Breg Cooling Control GroupExperimental Treatment3 Interventions
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centrexion Therapeutics
Lead Sponsor
Trials
14
Recruited
2,200+