A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
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
1 other identifier
interventional
332
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2018
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedStudy Start
First participant enrolled
September 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2020
CompletedResults Posted
Study results publicly available
July 21, 2022
CompletedJuly 21, 2022
July 1, 2022
1.8 years
August 27, 2018
March 16, 2022
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Baseline, Week 12
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
Baseline, Week 12
Mean Change From Study Baseline in WOMAC C (Function) Dimension
Baseline, Week12
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching placebo of 2.0 mL for IA injection
CNTX-4975-05
EXPERIMENTALPre-filled glass syringes administered as a single 2.0 mL IA injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Holland Center for Family Health
Glendale, Arizona, 85306, United States
GB Family Care
Phoenix, Arizona, 85037, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Med Center Medical Clinic
Carmichael, California, 95608, United States
TriWest Research Associates
El Cajon, California, 92020, United States
Arthritis Care and Research Center, Inc. (ACRC Studies)
Poway, California, 92064, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Panamerican Health Center, Inc.
Miami, Florida, 33126, United States
Well Pharma Medical Research, Corp
Miami, Florida, 33143, United States
Quality Research & Medical Center LLC
Miami, Florida, 33186, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
Journey Research, Inc.
Oldsmar, Florida, 34677, United States
M&M Clinical Trials Sunrise
Sunrise, Florida, 33351, United States
Conquest Research
Winter Park, Florida, 32789, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265, United States
Healthcare Research Network, LLC
Flossmoor, Illinois, 60422, United States
Affinity Clinical Research Institute
Oak Brook, Illinois, 60523, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
BTC of New Bedford, LLC
New Bedford, Massachusetts, 02740, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, 89119, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
North Charleston, South Carolina, 29406, United States
Heartland Medical, PC
New Tazewell, Tennessee, 37825, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Centrexion Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Randall Stevens, MD
Centrexion Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
September 7, 2018
Study Start
September 9, 2018
Primary Completion
June 11, 2020
Study Completion
June 11, 2020
Last Updated
July 21, 2022
Results First Posted
July 21, 2022
Record last verified: 2022-07