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

Phase 3

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: Placebo
Drug: CNTX-4975-05

Registration Number: NCT03660943

Lead Sponsor: Centrexion Therapeutics

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 332

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo of 2.0 mL for IA injection
CNTX-4975-05	CNTX-4975-05	Pre-filled glass syringes administered as a single 2.0 mL IA injection

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in WOMAC A (Pain) Dimension	Baseline, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee	Baseline, Week 12	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.
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension	Baseline, Week 12	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.
Mean Change From Study Baseline in WOMAC C (Function) Dimension	Baseline, Week12	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.

Trial Locations

Locations (30): Chase Medical Research, LLC
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Waterbury, Connecticut, United States
Holland Center for Family Health
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Glendale, Arizona, United States
TriWest Research Associates
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El Cajon, California, United States
The Center for Rheumatology and Bone Research
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Wheaton, Maryland, United States
Lillestol Research LLC
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Fargo, North Dakota, United States
M&M Clinical Trials Sunrise
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Sunrise, Florida, United States
Better Health Clinical Research, Inc.
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Newnan, Georgia, United States
Affinity Clinical Research Institute
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Oak Brook, Illinois, United States
Heartland Medical, PC
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New Tazewell, Tennessee, United States
Spectrum Medical, Inc.
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Danville, Virginia, United States
Healthcare Research Network
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Hazelwood, Missouri, United States
Healthcare Research Network, LLC
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Flossmoor, Illinois, United States
Drug Trials America
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Hartsdale, New York, United States
BTC of New Bedford, LLC
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New Bedford, Massachusetts, United States
Arthritis Care and Research Center, Inc. (ACRC Studies)
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Poway, California, United States
Journey Research, Inc.
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Oldsmar, Florida, United States
GB Family Care
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Phoenix, Arizona, United States
Arizona Research Center
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Phoenix, Arizona, United States
Med Center Medical Clinic
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Carmichael, California, United States
San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, United States
Panamerican Health Center, Inc.
🇺🇸
Miami, Florida, United States
Well Pharma Medical Research, Corp
🇺🇸
Miami, Florida, United States
Quality Research & Medical Center LLC
🇺🇸
Miami, Florida, United States
Conquest Research
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Winter Park, Florida, United States
DelRicht Research
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New Orleans, Louisiana, United States
Office of Robert P. Kaplan, DO
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Las Vegas, Nevada, United States
Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
🇺🇸
North Charleston, South Carolina, 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
First Surgical Hospital
🇺🇸
Bellaire, Texas, United States