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

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.

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
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Orthopaedic Center - Research
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research, Inc
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research, LLC
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • La Mesa, California, United States, 91942
      • BioSolutions Clinical Research Center
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research, Inc
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Miami, Florida, United States, 33185
      • M&M Medical Center, Inc
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
    • Orlando, Florida, United States, 32822
      • Jewett Orthopaedic
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Stockbridge, Georgia, United States, 30281
      • Atlanta Orthopaedic Institute, LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Mid America PolyClinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • North Attleboro, Massachusetts, United States, 02760
      • Tristan Medical Enterprises PC, dba
  • Michigan
    • Traverse City, Michigan, United States, 49686
      • Medical Research Associates, Inc
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Bone Joint & Spine Surgeons, Inc
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Ortho Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC

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 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.

Key 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 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.

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score	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
Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score	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 Baseline in WOMAC C (Physical Function) Dimension Total Score	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, Week 12

Collaborators and Investigators

• Sponsor: Centrexion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 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; analgesic; pain; knee pain; non-opioid; capsaicin; intra-articular
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CNTX-4975i-OA-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No