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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558439
• Other study ID #: 4975-OA-502
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2015
• Last updated: August 3, 2017
• Start date: August 2015
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• CNTX-4975

Other:
• Placebo

Locations

Country	Name	City	State
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	Dream Team Clinical Research, LLC	Anaheim	California
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Hope Clinical Research, LLC	Canoga Park	California
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	TriWest Research Associates	El Cajon	California
United States	Drug Trials America	Hartsdale	New York
United States	Eastern Research	Hialeah	Florida
United States	Finlay Research Clinic	Hialeah	Florida
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	BioSolutions Clinical Research Center	La Mesa	California
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	Axis Clinical Trials	Los Angeles	California
United States	M&M Medical Center, Inc	Miami	Florida
United States	Manhattan Medical Research Practice	New York	New York
United States	Compass Research, LLC	Orlando	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	University Orthopedics Center	State College	Pennsylvania
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Compass Research, LLC	The Villages	Florida
United States	Advanced Arizona Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question		Up to 4 weeks