A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

Osteoarthritis, Knee Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660943
• Other study ID #: CNTX-4975i-OA-304
• Status: Completed
• Phase: Phase 3
• Start date: September 9, 2018
• Est. completion date: June 11, 2020

Study information

• Verified date: July 2022
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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 the 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.

• Body Mass Index (BMI) =45 kg/m^2

• Must have failed 2 or more prior therapies.

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 the OA.

• Periarticular pain from any cause.

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Placebo
Receiving Placebo Injection
• CNTX-4975-05
Receiving CNTX-4975-05 Injection

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	Med Center Medical Clinic	Carmichael	California
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	TriWest Research Associates	El Cajon	California
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Healthcare Research Network, LLC	Flossmoor	Illinois
United States	Holland Center for Family Health	Glendale	Arizona
United States	Drug Trials America	Hartsdale	New York
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Office of Robert P. Kaplan, DO	Las Vegas	Nevada
United States	Panamerican Health Center, Inc.	Miami	Florida
United States	Quality Research & Medical Center LLC	Miami	Florida
United States	Well Pharma Medical Research, Corp	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	BTC of New Bedford, LLC	New Bedford	Massachusetts
United States	DelRicht Research	New Orleans	Louisiana
United States	Heartland Medical, PC	New Tazewell	Tennessee
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine	North Charleston	South Carolina
United States	Affinity Clinical Research Institute	Oak Brook	Illinois
United States	Journey Research, Inc.	Oldsmar	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	GB Family Care	Phoenix	Arizona
United States	Arthritis Care and Research Center, Inc. (ACRC Studies)	Poway	California
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	M&M Clinical Trials Sunrise	Sunrise	Florida
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in WOMAC A (Pain) Dimension	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
Secondary	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	Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension	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
Secondary	Mean Change From Study Baseline in WOMAC C (Function) Dimension	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, Week12