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Trial record 2 of 5 for:    CNTX-4975

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics
ClinicalTrials.gov Identifier:
NCT02558439
First received: September 20, 2015
Last updated: March 13, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Osteoarthritis
Drug: CNTX-4975
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centrexion Therapeutics:

Primary Outcome Measures:
  • Change from baseline to week 4 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 compared to placebo in subjects with osteoarthritis (OA) of the knee [ Time Frame: At 4 weeks ]

Secondary Outcome Measures:
  • Change from baseline to Week 4 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo [ Time Frame: At 4 weeks ]
  • Change from baseline to each study visit through week 12 in average index knee pain with walking using WOMAC A1 [ Time Frame: Up to 12 weeks ]
  • Change from baseline to each study visit Week 12-24 in the average index knee pain with walking using the WOMAC A1 question [ Time Frame: Up to 24 weeks ]
  • Responder analysis using OMERACT-OARSI responder criteria at each study visit for the index knee through week 24 [ Time Frame: Up to 24 weeks ]
  • Change from baseline to each study visit through week 24 in average physical function using the WOMAC C function subscale [ Time Frame: Up to 24 weeks ]
  • Safety and tolerability in subjects treated with CNTX-4975 compared with placebo measured by collection of adverse events, vital signs, clinical laboratory evaluation, ECGs, physical exam, concomitant medications and therapies [ Time Frame: Up to 24 weeks ]

Enrollment: 175
Study Start Date: August 2015
Study Completion Date: February 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02558439

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

Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT02558439     History of Changes
Other Study ID Numbers: 4975-OA-502
Study First Received: September 20, 2015
Last Updated: March 13, 2017

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 21, 2017