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



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 80
Updated:3/15/2017
Start Date:August 2015
End Date:February 2017

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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. 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

2. tests positive upon urine drug screen for a substance of abuse.

- Has moderate to severe depression or anxiety.
We found this trial at
22
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760 North Euclid Street
Anaheim, California 92801
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: Melanie VanDemark
Phone: 386-785-2400
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: Kevin Radbill
Phone: 407-426-9299
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Altoona, Pennsylvania 16602
Principal Investigator: Christopher McClellan
Phone: 814-949-4050
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Canoga Park, California 91303
Principal Investigator: Hessam Aazami
Phone: 818-999-4673
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Duncansville, Pennsylvania 16635
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El Cajon, California 92020
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Hartsdale, New York 10530
Principal Investigator: Statish Modugu
Phone: 914-341-2346
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Hialeah, Florida 33012
Principal Investigator: Maria Fernandez
Phone: 786-343-3902
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Hialeah, Florida 33013
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Kansas City, Missouri 64114
Principal Investigator: John Ervin
Phone: 816-943-0770
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La Mesa, California 91942
Principal Investigator: Peter Hanson
Phone: 619-315-0314
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Lauderdale Lakes, Florida 33319
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Los Angeles, California 90036
Principal Investigator: Lydia Hazan
Phone: 310-289-8242
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286 Westward Drive
Miami, Florida 33185
Principal Investigator: Ignacio Rodriguez
Phone: 305-480-0100
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New York, New York 10016
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Wayne Harper
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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State College, Pennsylvania 16801
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Stockbridge, Georgia 30281
Principal Investigator: Nathan Segall
Phone: 770-507-6867
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The Villages, Florida 32162
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Tuscon, Arizona 85712
Principal Investigator: Dena Petersen
Phone: 520-612-7860
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