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

Centrexion Therapeutics28 个研究点分布在 1 个国家目标入组 854 人开始时间: 2018年9月18日最近更新: 2022年3月9日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 854
试验地点: 28
主要终点: Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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 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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 40 Years 至 95 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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-
•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.
•These subjects may have:
•unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
•unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-
•For subjects for bilateral knee injection, the index knee must have moderate to severe pain at screening associated with OA, and greater pain in the index knee than in the contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. The index knee in these subjects is the one with the worst pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.
•For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst possible pain) to rate their knee pain with walking (both knees, except knees with PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a qualifying pain score.
•Body mass index ≤45 kg/m^

排除标准

•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.

研究组 & 干预措施

Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine

Experimental

Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.

干预措施: ElastoGel (Device)

Breg Cooling Control Group

Experimental

Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.

干预措施: CNTX-4975-05 (Drug)

Breg Cooling Control Group

Experimental

Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.

干预措施: Lidocaine without epinephrine (Drug)

Breg Cooling Control Group

Experimental

Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.

干预措施: Breg Ice Water Pump (Device)