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

Sponsor

Centrexion Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT02558439

Collaborator

(none)

175

Enrollment

Locations

Arms

18.1

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: CNTX-4975 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [At 12 Weeks]

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 [At 12 Weeks]
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]
Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question [Up to 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
2	Advanced Arizona Clinical Research	Tucson	Arizona	United States	85704
3	Dream Team Clinical Research, LLC	Anaheim	California	United States	92801
4	Hope Clinical Research, LLC	Canoga Park	California	United States	91303
5	TriWest Research Associates	El Cajon	California	United States	92020
6	BioSolutions Clinical Research Center	La Mesa	California	United States	91941
7	Axis Clinical Trials	Los Angeles	California	United States	90036
8	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
9	Finlay Research Clinic	Hialeah	Florida	United States	33012
10	Eastern Research	Hialeah	Florida	United States	33013
11	Sunrise Medical Research	Lauderdale Lakes	Florida	United States	33319
12	M&M Medical Center, Inc	Miami	Florida	United States	85704
13	Compass Research, LLC	Orlando	Florida	United States	32806
14	Compass Research, LLC	The Villages	Florida	United States	32162
15	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
16	The Center for Pharmaceutical Research	Kansas City	Missouri	United States	64114
17	Drug Trials America	Hartsdale	New York	United States	10530
18	Manhattan Medical Research Practice	New York	New York	United States	10016
19	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
20	University Orthopedics Center	Altoona	Pennsylvania	United States	16602
21	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
22	University Orthopedics Center	State College	Pennsylvania	United States	16801

Sponsors and Collaborators

Centrexion Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centrexion Therapeutics

ClinicalTrials.gov Identifier:

NCT02558439

Other Study ID Numbers:

4975-OA-502

First Posted:

Sep 24, 2015

Last Update Posted:

Aug 8, 2017

Last Verified:

Jul 1, 2017

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 8, 2017