Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
1 other identifier
interventional
175
1 country
22
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2015
Shorter than P25 for phase_2
22 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
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 8, 2017
July 1, 2017
1.2 years
September 20, 2015
August 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
At 12 Weeks
Secondary Outcomes (3)
Change from Baseline through Week 12 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo
At 12 Weeks
Change from Baseline to each study visit through Week 24 in average index knee pain with walking using WOMAC A1 in subjects treated with CNTX-4975 compared to placebo
Up to 24 weeks
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question
Up to 4 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORSubjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.
0.5 mg CNTX-4975
EXPERIMENTALSubjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
1.0 mg CNTX-4975
EXPERIMENTALSubjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
Interventions
Eligibility Criteria
You may qualify if:
- Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
- 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.
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 12 months.
- 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:
- 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
- tests positive upon urine drug screen for a substance of abuse.
- Has moderate to severe depression or anxiety.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Advanced Arizona Clinical Research
Tucson, Arizona, 85704, United States
Dream Team Clinical Research, LLC
Anaheim, California, 92801, United States
Hope Clinical Research, LLC
Canoga Park, California, 91303, United States
TriWest Research Associates
El Cajon, California, 92020, United States
BioSolutions Clinical Research Center
La Mesa, California, 91941, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Finlay Research Clinic
Hialeah, Florida, 33012, United States
Eastern Research
Hialeah, Florida, 33013, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
M&M Medical Center, Inc
Miami, Florida, 85704, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Compass Research, LLC
The Villages, Florida, 32162, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Manhattan Medical Research Practice
New York, New York, 10016, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Related Publications (1)
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.
PMID: 30888737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2015
First Posted
September 24, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
February 1, 2017
Last Updated
August 8, 2017
Record last verified: 2017-07