Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
NCT ID: NCT02558439
Last Updated: 2017-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2015-08-31
2017-02-28
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
TRIPLE
Study Groups
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Placebo
Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.
Placebo
0.5 mg CNTX-4975
Subjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
CNTX-4975
1.0 mg CNTX-4975
Subjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
CNTX-4975
Interventions
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CNTX-4975
Placebo
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
* A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
* Specified baseline and screening scores on the WOMAC A1
* Body Mass Index ≤ 45 kg/m2.
* Subjects must have had a therapeutic failure (no relief, or inadequate relief), and/or AEs resulting in stopping treatment, and/or contraindication to the standard of care appropriate to the severity of the index knee OA pain they are experiencing.
Exclusion Criteria
* Prior arthroscopic surgery of the index knee within 3 months of Screening.
* Any painful conditions of the index knee due to joint disease other than OA.
* Mild pain in the non-index knee when walking.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Secondary OA of the index knee due to acute traumatic injury.
* Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) or misalignment (\> 10 degrees varus or valgus) of the index knee
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Corticosteroid injection in the index knee within 90 days of Screening.
* Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
* Prior participation in an ALGRX 4975 or CNTX-4975 study.
* Has any of the following characteristics:
1. active or historic substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, or
2. tests positive upon urine drug screen for a substance of abuse.
* Has moderate to severe depression or anxiety.
45 Years
80 Years
ALL
No
Sponsors
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Centrexion Therapeutics
INDUSTRY
Responsible Party
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Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Advanced Arizona Clinical Research
Tucson, Arizona, United States
Dream Team Clinical Research, LLC
Anaheim, California, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
TriWest Research Associates
El Cajon, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Finlay Research Clinic
Hialeah, Florida, United States
Eastern Research
Hialeah, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
M&M Medical Center, Inc
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Compass Research, LLC
The Villages, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Drug Trials America
Hartsdale, New York, United States
Manhattan Medical Research Practice
New York, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Countries
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References
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Stevens RM, Ervin J, Nezzer J, Nieves Y, Guedes K, Burges R, Hanson PD, Campbell JN. Randomized, Double-Blind, Placebo-Controlled Trial of Intraarticular Trans-Capsaicin for Pain Associated With Osteoarthritis of the Knee. Arthritis Rheumatol. 2019 Sep;71(9):1524-1533. doi: 10.1002/art.40894. Epub 2019 Jul 17.
Other Identifiers
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4975-OA-502
Identifier Type: -
Identifier Source: org_study_id
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