A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
1 other identifier
interventional
332
1 country
33
Brief Summary
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2018
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2018
CompletedFirst Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2019
CompletedResults Posted
Study results publicly available
April 8, 2022
CompletedJuly 26, 2022
July 1, 2022
1.8 years
January 31, 2018
March 16, 2022
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
Baseline, Week 12
Secondary Outcomes (3)
Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
Baseline, Week 12
Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
Baseline, Week 12
Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
Baseline, Week 12
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching placebo of 2.0 mL for IA injection
CNTX-4975-05
EXPERIMENTALPre-filled glass syringes administered as a single 2.0 mL IA injection
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.
- 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.
You may not qualify if:
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Alabama Orthopaedic Center - Research
Birmingham, Alabama, 35209, United States
Cahaba Research, Inc
Birmingham, Alabama, 35242, United States
Coastal Clinical Research, Inc
Mobile, Alabama, 36608, United States
Noble Clinical Research, LLC
Tucson, Arizona, 85704, United States
Orange County Research Institute
Anaheim, California, 92801, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Biosolutions Clinical Research Center
La Mesa, California, 91942, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Tampa Bay Medical Research, Inc
Clearwater, Florida, 33761, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
M&M Medical Center, Inc
Miami, Florida, 33185, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Jewett Orthopaedic
Orlando, Florida, 32822, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, 30281, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Mid America PolyClinic
Overland Park, Kansas, 66210, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Tristan Medical Enterprises PC, dba
North Attleboro, Massachusetts, 02760, United States
Medical Research Associates, Inc
Traverse City, Michigan, 49686, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Bone Joint & Spine Surgeons, Inc
Toledo, Ohio, 43623, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Clinical Investigations of Texas
Plano, Texas, 75075, United States
Ortho Virginia
Arlington, Virginia, 22205, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Centrexion Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Randall M. Stevens, MD
Centrexion Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2018
First Posted
February 12, 2018
Study Start
January 24, 2018
Primary Completion
November 22, 2019
Study Completion
November 22, 2019
Last Updated
July 26, 2022
Results First Posted
April 8, 2022
Record last verified: 2022-07