A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Placebo; Drug: CNTX-4975-05

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Holland Center for Family Health
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85037
      • GB Family Care
  • California
    • Carmichael, California, United States, 95608
      • Med Center Medical Clinic
    • El Cajon, California, United States, 92020
      • Triwest Research Associates
    • Poway, California, United States, 92064
      • Arthritis Care and Research Center, Inc. (ACRC Studies)
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research, Corp
    • Miami, Florida, United States, 33126
      • Panamerican Health Center, Inc.
    • Miami, Florida, United States, 33186
      • Quality Research & Medical Center LLC
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Oldsmar, Florida, United States, 34677
      • Journey Research, Inc.
    • Sunrise, Florida, United States, 33351
      • M&M Clinical Trials Sunrise
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc.
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network, LLC
    • Oak Brook, Illinois, United States, 60523
      • Affinity Clinical Research Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford, LLC
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Office of Robert P. Kaplan, DO
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
  • Tennessee
    • New Tazewell, Tennessee, United States, 37825
      • Heartland Medical, PC
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Surgical Hospital
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc
    • San Antonio, Texas, United States, 78258
      • DCT-Stone Oak, LLC dba Discovery Clinical Trials
  • Virginia
    • Danville, Virginia, United States, 24541
      • Spectrum Medical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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 the 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.
• Body Mass Index (BMI) ≤45 kg/m^2
• Must have failed 2 or more prior therapies.

Exclusion Criteria:

• 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 the OA.
• Periarticular pain from any cause.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo of 2.0 mL for IA injection	Drug: Placebo; Receiving Placebo Injection
Experimental: CNTX-4975-05; Pre-filled glass syringes administered as a single 2.0 mL IA injection	Drug: CNTX-4975-05; Receiving CNTX-4975-05 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in WOMAC A (Pain) Dimension	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.	Baseline, Week 12
Mean Change From Study Baseline in WOMAC C (Function) Dimension	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.	Baseline, Week12

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics
• Investigators: Study Chair: Randall Stevens, MD, Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CNTX-4975i-OA-304

Drug and device information, study documents

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