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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02558439

Run by

Centrexion Therapeutics

People needed

175

Starts

2015-08-01

Expected to finish

2017-02-01

Last updated by the study team

2017-08-08

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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 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.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Advanced Arizona Clinical Research — Tucson, Arizona, United States
• Dream Team Clinical Research, LLC — Anaheim, California, United States
• Hope Clinical Research, LLC — Canoga Park, California, United States
• TriWest Research Associates — El Cajon, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Finlay Research Clinic — Hialeah, Florida, United States
• Eastern Research — Hialeah, Florida, United States
• Sunrise Medical Research — Lauderdale Lakes, Florida, United States
• M&M Medical Center, Inc — Miami, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Compass Research, LLC — The Villages, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Drug Trials America — Hartsdale, New York, United States
• Manhattan Medical Research Practice — New York, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States

Full record on ClinicalTrials.gov

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