ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03661996
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Brief Summary:
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 1.0 mg 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: CNTX-4975-05 Drug: Lidocaine without epinephrine Device: ElastoGel Device: Breg Ice Water Pump Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Breg Cooling Control Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
Other Name: trans-capsaicin

Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection

Device: Breg Ice Water Pump
Cooling Device

Experimental: Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
Other Name: trans-capsaicin

Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection

Device: ElastoGel
Cooling Device

Experimental: Shortened Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
Other Name: trans-capsaicin

Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection

Device: ElastoGel
Cooling Device

Experimental: Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
Other Name: trans-capsaicin

Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection

Device: ElastoGel
Cooling Device

Experimental: Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine
Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
Other Name: trans-capsaicin

Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection

Device: ElastoGel
Cooling Device




Primary Outcome Measures :
  1. Determination of Optimal Procedure for Administering CNTX-4975-05 with Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction [ Time Frame: Study Start to Day 3 after Treatment ]
    Equally-weighted, combined score calculated for the 5 treatment regimens by assessing pain using 0-4 scale of none, mild, moderate, moderately severe, and severe; (2) assessment of the participant's satisfaction with the treatment regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied); and (3) assessment of the investigator's satisfaction with the treatment regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied).


Secondary Outcome Measures :
  1. OMERACT-OARSI Percent of Responders after a Single Injection into the Index Knee [ Time Frame: Study Start to Week 8 ]
    Percent of responders based on the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders at Week 8 for participants with a single CNTX-4975-05 joint injection (index knee, moderate to severe pain index knee, pain not >3 for contralateral knee).

  2. OMERACT-OARSI Percent of Responders after a Single Injection into both Knees [ Time Frame: Study Start to Week 8 ]
    Percent of OMERACT-OARSI responders at Week 8 for participants with bilateral knee injections of CNTX-4975-05 (index knee, moderate to severe pain index knee, both knees meeting OMERACT-OARSI responder criteria).

  3. OMERACT-OARSI Percent of Responders after a Single Injection into the Index Knee [ Time Frame: Study Start to Week 8 ]
    Percent of OMERACT-OARSI responders at Week 8 for participants with a single CNTX-4975-05 joint injection (population with index knee, moderate to severe pain index knee, non-index knee with partial joint replacement [PJR]/ total joint replacement [TJR]).

  4. KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: Study Start to Week 8 ]
    For each of the 3 types of participants, the absolute change; the number of participants who have ≥30%, ≥50%, ≥70%, or ≥90% improvement at week 8; and on the 5 subscales (pain, other symptoms, activities of daily living, sports and recreation, quality of life) of the KOOS at Week 8.

  5. Participant Satisfaction of Treatment Rated Using Questionnaire [ Time Frame: Study Start to Week 8 ]
    Assess subject satisfaction of treatment with CNTX-4975-05 IA injection for each of the 3 types of participants, and all participants in the trial, on a scale of 1 (completely dissatisfied) to 7 (completely satisfied) at week 8.

  6. Participant Satisfaction of Partial Joint Replacement/Total Joint Replacement (PJR/TJR) Rated Using Questionnaire [ Time Frame: Study Start to Week 8 ]
    For subject with PJR/TJR, assess satisfaction with CNTX-4975-05 IA injection versus satisfaction with the knee with a PJR/TJR on a scale of 1 (completely dissatisfied) to 7 (completely satisfied).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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
  • For subjects for monoarticular knee injection, the index knee must have moderate to severe pain at screening associated with OA, which must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
  • Body mass index ≤45 kg/m^2.

Key Exclusion Criteria:

  • Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months. Joint replacement of the contralateral knee is permitted for subjects who will not receive an injection in the contralateral (natural) knee.
  • Prior arthroscopic surgery of the index knee within 6 months of Screening.
  • Any painful conditions of the index knee due to joint disease other than OA. Radicular or referred pain involving the index knee or from joint disease other than OA involving the index knee, such as, but not restricted to chondromalacia patellae, inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
  • Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
  • Other chronic pain anywhere in the body that requires the use of chronic analgesic medications, including, but not limited to, local painful areas, myofascial pain syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661996


Contacts
Contact: Study Manager 617-837-6911 info@centrexion.com

Locations
United States, Alabama
Alabama Orthopaedic Center-Research Recruiting
Birmingham, Alabama, United States, 35209
United States, Arizona
Holland Center for Family Health Recruiting
Peoria, Arizona, United States, 85381
Noble Clinical Research Recruiting
Tucson, Arizona, United States, 85704
United States, California
Med Center Medical Clinic Recruiting
Carmichael, California, United States, 95608
Core Healthcare Group Recruiting
Cerritos, California, United States, 90703
Encompass Clinical Research Recruiting
Spring Valley, California, United States, 91978
United States, Florida
M&M Medical Center, Inc. Recruiting
Miami, Florida, United States, 33185
United States, Georgia
Georgia Institute for Clinical Research, LLC Recruiting
Marietta, Georgia, United States, 30060
Atlanta Orthopaedic Institute, LLC Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Healthcare Research Network II, LLC Recruiting
Flossmoor, Illinois, United States, 60422
United States, Indiana
MediSphere Medical Research Center, LLC Recruiting
Evansville, Indiana, United States, 47714
United States, Missouri
Healthcare Research Network Recruiting
Hazelwood, Missouri, United States, 63042
Center for Pharmaceutical Research, LLC Recruiting
Kansas City, Missouri, United States, 64114
United States, Nevada
Office of Robert P. Kaplan, DO Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, South Dakota
Meridian Clinical Research, LLC Recruiting
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
Study Chair: Randall M. Stevens, MD Centrexion Therapeutics Corp

Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT03661996     History of Changes
Other Study ID Numbers: CNTX-4975i-OA-303
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centrexion Therapeutics:
Osteoarthritis
Knee Pain
non opioid

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Epinephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics