A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
NCT ID: NCT03429049
Last Updated: 2022-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
332 participants
INTERVENTIONAL
2018-01-24
2019-11-22
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
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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CNTX-4975-05
Receiving CNTX-4975-05 injection
Placebo
Receiving Placebo injection
Eligibility Criteria
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Inclusion Criteria
* Confirmation of osteoarthritis (OA) of the knee.
* Confirmation of 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.
* BMI ≤45 kg/m\^2.
* Must have failed 2 or more prior therapies.
* Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.
* Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week 12. The current pain medication must be taken only for pain in the index knee, and not for another pain indication.
* Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.
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.
* Periarticular pain from any cause.
* Pain in the non-index knee that is \>3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
* 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 M. Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics
Locations
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Alabama Orthopaedic Center - Research
Birmingham, Alabama, United States
Cahaba Research, Inc
Birmingham, Alabama, United States
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Noble Clinical Research, LLC
Tucson, Arizona, United States
Orange County Research Institute
Anaheim, California, United States
Core Healthcare Group
Cerritos, California, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Providence Clinical Research
North Hollywood, California, United States
Medical Associates Research Group
San Diego, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Tampa Bay Medical Research, Inc
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
M&M Medical Center, Inc
Miami, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Jewett Orthopaedic
Orlando, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Mid America PolyClinic
Overland Park, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Tristan Medical Enterprises PC, dba
North Attleboro, Massachusetts, United States
Medical Research Associates, Inc
Traverse City, Michigan, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Bone Joint & Spine Surgeons, Inc
Toledo, Ohio, United States
Tekton Research, Inc
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Clinical Investigations of Texas
Plano, Texas, United States
Ortho Virginia
Arlington, Virginia, United States
Charlottesville Medical Research Center, LLC
Charlottesville, 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-301
Identifier Type: -
Identifier Source: org_study_id
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