An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
NCT ID: NCT03661996
Last Updated: 2022-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
854 participants
INTERVENTIONAL
2018-09-18
2019-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Breg Cooling Control Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Breg Ice Water Pump
Cooling Device
Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
ElastoGel
Cooling Device
Shortened Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
ElastoGel
Cooling Device
Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
ElastoGel
Cooling Device
Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine
Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
ElastoGel
Cooling Device
Interventions
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CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
ElastoGel
Cooling Device
Breg Ice Water Pump
Cooling Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
These subjects may have:
1. unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
2. unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-05.
For subjects for bilateral knee injection, the index knee must have moderate to severe pain at screening associated with OA, and greater pain in the index knee than in the contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. The index knee in these subjects is the one with the worst pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.
For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst possible pain) to rate their knee pain with walking (both knees, except knees with PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a qualifying pain score.
* Body mass index ≤45 kg/m\^2.
Exclusion Criteria
* 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.
40 Years
95 Years
ALL
No
Sponsors
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Centrexion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Randall M. Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics Corp
Locations
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Alabama Orthopaedic Center-Research
Birmingham, Alabama, United States
Holland Center for Family Health
Peoria, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Med Center Medical Clinic
Carmichael, California, United States
Core Healthcare Group
Cerritos, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Conquest Clinical Research
Maitland, Florida, United States
F&T Medical Research, Inc.
Miami, Florida, United States
M&M Medical Center, Inc.
Miami, Florida, United States
Charter Research
Mt. Dora, Florida, United States
Premier MED Family & Sports Medicine
Ocoee, Florida, United States
Ascension Research
Pinellas Park, Florida, United States
M&M Clinical Trials Sunrise
Sunrise, Florida, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Affinity Health
Oak Brook, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
First Surgical Hospital
Bellaire, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CNTX-4975i-OA-303
Identifier Type: -
Identifier Source: org_study_id
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