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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03660943

Run by

Centrexion Therapeutics

People needed

332

Starts

2018-09-09

Expected to finish

2020-06-11

Last updated by the study team

2022-07-21

Who can join

Age: 40 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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