Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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:
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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.
0.5 mg CNTX-4975	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.
1.0 mg CNTX-4975	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (20): Advanced Arizona Clinical Research
🇺🇸
Tucson, Arizona, United States
Dream Team Clinical Research, LLC
🇺🇸
Anaheim, California, United States
TriWest Research Associates
🇺🇸
El Cajon, California, United States
Eastern Research
🇺🇸
Hialeah, Florida, United States
Sunrise Medical Research
🇺🇸
Lauderdale Lakes, Florida, United States
Finlay Research Clinic
🇺🇸
Hialeah, Florida, United States
Avail Clinical Research, LLC
🇺🇸
DeLand, Florida, United States
Clinical Research Atlanta
🇺🇸
Stockbridge, Georgia, United States
Compass Research, LLC
🇺🇸
The Villages, Florida, United States
Drug Trials America
🇺🇸
Hartsdale, New York, United States
Wake Research Associates, LLC
🇺🇸
Raleigh, North Carolina, United States
Manhattan Medical Research Practice
🇺🇸
New York, New York, United States
University Orthopedics Center
🇺🇸
State College, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Hope Clinical Research, LLC
🇺🇸
Canoga Park, California, United States
BioSolutions Clinical Research Center
🇺🇸
La Mesa, California, United States
Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
The Center for Pharmaceutical Research
🇺🇸
Kansas City, Missouri, United States
Achieve Clinical Research, LLC
🇺🇸
Birmingham, Alabama, United States
M&M Medical Center, Inc
🇺🇸
Miami, Florida, United States