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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CNTX-4975
Placebo
Sponsored by
Centrexion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Achieve Clinical Research, LLC
  • Advanced Arizona Clinical Research
  • Dream Team Clinical Research, LLC
  • Hope Clinical Research, LLC
  • TriWest Research Associates
  • BioSolutions Clinical Research Center
  • Axis Clinical Trials
  • Avail Clinical Research, LLC
  • Finlay Research Clinic
  • Eastern Research
  • Sunrise Medical Research
  • M&M Medical Center, Inc
  • Compass Research, LLC
  • Compass Research, LLC
  • Clinical Research Atlanta
  • The Center for Pharmaceutical Research
  • Drug Trials America
  • Manhattan Medical Research Practice
  • Wake Research Associates, LLC
  • University Orthopedics Center
  • Altoona Center for Clinical Research
  • University Orthopedics Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

0.5 mg CNTX-4975

1.0 mg CNTX-4975

Arm Description

Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question

Full Information

First Posted
September 20, 2015
Last Updated
August 3, 2017
Sponsor
Centrexion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02558439
Brief Title
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.
Arm Title
0.5 mg CNTX-4975
Arm Type
Experimental
Arm Description
Subjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
Arm Title
1.0 mg CNTX-4975
Arm Type
Experimental
Arm Description
Subjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
Intervention Type
Drug
Intervention Name(s)
CNTX-4975
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
At 12 Weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
At 12 Weeks
Title
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
Time Frame
Up to 24 weeks
Title
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 tests positive upon urine drug screen for a substance of abuse. Has moderate to severe depression or anxiety.
Facility Information:
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Advanced Arizona Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Dream Team Clinical Research, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Hope Clinical Research, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
TriWest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
BioSolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91941
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Finlay Research Clinic
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Eastern Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Sunrise Medical Research
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
M&M Medical Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
85704
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Compass Research, LLC
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Manhattan Medical Research Practice
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30888737
Citation
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.
Results Reference
derived

Learn more about this trial

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

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