NCT02678793已完成2 期
An Open-Label, Multiple-Dose Extension Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
Centrexion Therapeutics9 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 9
- 主要终点
- Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests
研究概览
简要总结
Subjects who have completed study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged >18 years at the time of the Screening Visit.
- •Completion of study 4975-MN-
- •Female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period:
- •Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (IP) administration.
- •Total abstinence from sexual intercourse since the last menses before IP administration.
- •Intrauterine device.
- •Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream).
- •Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and weekly IWRS/IVRS entries, and to communicate meaningfully with the study personnel.
- •Signed an Informed Consent Form approved by the Institutional Review Board.
- •Subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after Screening.
排除标准
- •Other chronic pain anywhere in the body that is severe in intensity or would interfere with the subject's ability to evaluate foot pain from intermetatarsal neuroma.
- •Signs of arterial insufficiency in the feet, including clinically meaningful edema.
- •Raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot.
- •Daily use of opioids for any condition.
- •Corticosteroid injection in the affected foot within 30 days of Screening.
- •Presence of any medical condition (or taking any medication) or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
- •Clinically significant abnormal laboratory result at the Screening Visit (in the opinion of the investigator).
- •Has a positive pregnancy test at the Screening Visit.
研究组 & 干预措施
Subjects who have completed Study 4975-MN-202 will be eligible
Other
Subjects who have completed Study 4975-MN-202 will be eligible to receive open-label treatment with CNTX-4975 200 μg in Study 4975-MN-203 if they meet the inclusion/exclusion criteria.
干预措施: CNTX-4975 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of repeat injections of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests
时间窗: over the course of 1 year.
Evaluate the safety and tolerability of repeat injections of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events
时间窗: over the course of 1 year.
次要结局
- To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in NPRS.(over the course of 1 year.)
- To evaluate the analgesic efficacy of repeat doses of CNTX-4975 by change in Patient Global Impression of Change(over the course of 1 year.)
研究者
研究点 (9)
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