A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
NCT ID: NCT03660943
Last Updated: 2022-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
332 participants
INTERVENTIONAL
2018-09-09
2020-06-11
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
QUADRUPLE
Study Groups
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Placebo
Matching placebo of 2.0 mL for IA injection
Placebo
Receiving Placebo Injection
CNTX-4975-05
Pre-filled glass syringes administered as a single 2.0 mL IA injection
CNTX-4975-05
Receiving CNTX-4975-05 Injection
Interventions
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Placebo
Receiving Placebo Injection
CNTX-4975-05
Receiving CNTX-4975-05 Injection
Eligibility Criteria
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Inclusion Criteria
* Confirmation of osteoarthritis (OA) of the knee.
* Confirmation of the OA of the index knee.
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
* Body Mass Index (BMI) ≤45 kg/m\^2
* Must have failed 2 or more prior therapies.
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 the OA.
* Periarticular pain from any cause.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Instability of the index knee.
* Misalignment (\>10 degrees varus or valgus) of the index knee on standing.
* Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
* Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
* Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Current use of opioids for any condition other than for OA of the index knee.
* Corticosteroid injection into the index knee within 90 days of Screening.
* Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.
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 Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics
Locations
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Holland Center for Family Health
Glendale, Arizona, United States
GB Family Care
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Med Center Medical Clinic
Carmichael, California, United States
TriWest Research Associates
El Cajon, California, United States
Arthritis Care and Research Center, Inc. (ACRC Studies)
Poway, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Panamerican Health Center, Inc.
Miami, Florida, United States
Well Pharma Medical Research, Corp
Miami, Florida, United States
Quality Research & Medical Center LLC
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Journey Research, Inc.
Oldsmar, Florida, United States
M&M Clinical Trials Sunrise
Sunrise, Florida, United States
Conquest Research
Winter Park, Florida, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, United States
Healthcare Research Network, LLC
Flossmoor, Illinois, United States
Affinity Clinical Research Institute
Oak Brook, Illinois, United States
DelRicht Research
New Orleans, Louisiana, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
BTC of New Bedford, LLC
New Bedford, Massachusetts, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, United States
Drug Trials America
Hartsdale, New York, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
North Charleston, South Carolina, United States
Heartland Medical, PC
New Tazewell, Tennessee, United States
First Surgical Hospital
Bellaire, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Spectrum Medical, Inc.
Danville, Virginia, 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-304
Identifier Type: -
Identifier Source: org_study_id
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