jRCT2080220444已完成3 期
Phase III study of FTB-8127 in patients with post-herpetic neuralgia (A placebo-controlled, multicenter, double-blind, parallel-group study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Study.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patients who have been over 3 months after the onset of herpes zoster
- •(2) Patients aged 20 years or older at the time of informed consent
- •(3) Patients providing written informed consent about participation in this clinical trial
- •(4) Hospitalized patients and outpatients. In outpatients, who may be able to visit once a week
- •(5) Patients who have been treated with drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics adjuvants for PHN within 2 weeks before the start of the pre-observation period
- •(6) In case of undergoing nerve block therapy, patients who are treated regularly (once a week or once every 2 weeks) or may be able to be treated regularly for 2 weeks before the start of the pre-observation period
- •(7) Out of 7 days of the pre-observation period (measured three times a day in the morning, daytime, and night), patients getting a maximum daily VAS pain score of 40 or more and having been gotten a maximum daily pain degree (Verbal Rating Scale: VRS) of moderate to severe for 4 days or more respectively
排除标准
- •(1) Patients with head disorders or brain lesions who are suspected of obnubilation
- •(2) Patients with a history or complication of elevated intracranial pressure
- •(3) Patients with consciousness disorders (e.g., unable to speak) or convulsions (e.g., status epilepticus)
- •(4) Patients with serious respiratory depression and pulmonary function impairment
- •(5) Patients with a history or complication of malignancies
- •(6) Patients with a history of hypersensitivity to opioid analgesics
- •(7) Patients who used opioid analgesics within 4 weeks before the start of the pre-observation period
- •(8) Patients who are drug addicts or drug abusers or who have a history of drug dependence
- •(9) Patients who are pregnant, lactating, or who have the possibility of pregnancy, or who wish to become pregnant during the clinical trial period
- •(10) Patients who participated in another clinical trial within 90 days before the start of the pre-observation period
- •(11) Patients with AST (GOT), ALT (GPT) of 100IU/L or more, total bilirubin of 3.0mg/dL or more, and serum creatinine of 2.0mg/dL or more on laboratory data up to 4 weeks before the start of the pre-observation period
- •(12) Patients who started the following pain relief treatments during the pre-observation period
- •Opioid analgesics, non-opioid analgesics, analgesics adjuvants, nerve block
- •Surgery that may affect pain assessment
- •Prohibited drugs (barbiturate derivatives, MAO inhibitors, CYP3A4 inhibitors)
- •(13) Patients who are judged to be inadequate by the investigator, etc
结局指标
主要结局
-
efficacy confirmatory -
次要结局
未报告次要终点
研究者
研究点 (1)
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