A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 95
Updated:3/8/2019
Start Date:September 25, 2018
End Date:December 2019
Contact:Study Manager
Email:info@centrexion.com
Phone:617-837-6911

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An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain

This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and
ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a
single intra-articular (IA) injection, in one or both knees, of 1.0 mg of CNTX-4975-05 in
subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA
injection of the investigational product, CNTX-4975-05, will be controlled primarily through
adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.


Key Inclusion Criteria:

- Male or female subjects between 40 and 95 years of age (inclusive)

- Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using
standard standing films (scored by the investigator) or using the fixed flexion
method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.

- Confirmation of OA of the index knee: American College of Rheumatology (ACR)
diagnostic criteria

- For subjects for monoarticular knee injection, the index knee must have moderate to
severe pain at screening associated with OA, which must be stable for a minimum of 6
months prior to Screening, as assessed by the investigator.

- Body mass index ≤45 kg/m^2.

Key Exclusion Criteria:

- Joint replacement surgery of the index knee at any time, or open surgery of the index
knee in the past 24 months. Joint replacement of the contralateral knee is permitted
for subjects who will not receive an injection in the contralateral (natural) knee.

- 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 OA. Radicular
or referred pain involving the index knee or from joint disease other than OA
involving the index knee, such as, but not restricted to chondromalacia patellae,
inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis,
acromegaly, etc.

- Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft
tissue tenderness, or subacute/acute pain from injury.

- Other chronic pain anywhere in the body that requires the use of chronic analgesic
medications, including, but not limited to, local painful areas, myofascial pain
syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic
pain.
We found this trial at
25
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Sunrise, Florida 33351
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Berlin, New Jersey
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Berlin, NJ
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Birmingham, Alabama 35209
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Carmichael, California 95608
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Cerritos, California 90703
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Dakota Dunes, South Dakota 57049
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Dallas, TX
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Evansville, Indiana 47714
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Evansville, IN
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232 Main Street Northwest
Flossmoor, Illinois 60422
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Hazelwood, Missouri 63042
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Houston, Texas 77004
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Kansas City, Missouri 64114
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Las Vegas, Nevada 89119
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Las Vegas, NV
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Marietta, GA
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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286 Westward Drive
Miami, Florida 33185
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New Orleans, Louisiana 70124
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Oak Brook, Illinois 60523
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Peoria, Arizona 85381
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Pinellas Park, Florida 33781
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Spring Valley, California 91978
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Stockbridge, Georgia 30281
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Tucson, Arizona 85704
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Winston-Salem, North Carolina 27103
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