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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Placebo; Drug: CNTX-4975

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Advanced Arizona Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Dream Team Clinical Research, LLC
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC
    • El Cajon, California, United States, 92020
      • Triwest Research Associates
    • La Mesa, California, United States, 91941
      • Biosolutions Clinical Research Center
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Hialeah, Florida, United States, 33012
      • Finlay Research Clinic
    • Hialeah, Florida, United States, 33013
      • Eastern Research
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Miami, Florida, United States, 85704
      • M&M Medical Center, Inc
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • The Villages, Florida, United States, 32162
      • Compass Research, LLC
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.	Other: Placebo
Experimental: 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.	Drug: CNTX-4975
Experimental: 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.	Drug: CNTX-4975

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 20, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 4975-OA-502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No