NCT06708416已完成2 期
A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Postherpetic Neuralgia
Ono Pharmaceutical Co., Ltd.52 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年2月12日最近更新:
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
- 142
- 试验地点
- 52
- 主要终点
- Change in weekly mean of average pain score (last 7-day mean of past 24-hour average pain scores [NRS] in the pain diary) from baseline to Week 8 of the treatment period
研究概览
简要总结
To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia
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
- Double (Participant, Investigator)
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
- •Japanese (both sexes)
- •Age (at the time of informed consent): 18 years and older
- •Outpatient
- •Patients with persistent pain ≥3 months (90 days) after the onset of herpes zoster
- •Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
排除标准
- •Patients who previously underwent neurodestruction or neurosurgical therapy for PHN
- •Patients with pain other than PHN that may affect assessments in this study
- •Patients with any skin condition related to the site of herpes zoster that may affect assessments in this study
- •Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
- •Patients with concurrent psychiatric diseases that may affect assessments in this study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo tablets once daily
干预措施: Placebo (Drug)
ONO-1110
Experimental
ONO-1110 tablets once a day
干预措施: ONO-1110 (Drug)
结局指标
主要结局
Change in weekly mean of average pain score (last 7-day mean of past 24-hour average pain scores [NRS] in the pain diary) from baseline to Week 8 of the treatment period
时间窗: Up to 15 weeks
Adverse Events
时间窗: Up to 15 weeks
次要结局
- Change in weekly mean of average pain score from baseline to each week(Up to 15 weeks)
- 30%- and 50%-responder rates based on the weekly mean of average pain score (proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively)(Up to 15 weeks)
- Change in weekly mean of worst pain score (last 7-day mean of past 24-hour worst pain scores [NRS] in the pain diary) from baseline to each week(Up to 15 weeks)
- 30%- and 50%-responder rates based on the weekly mean of worst pain score (proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively)(Up to 15 weeks)
- Change in Brief pain inventory-short form (BPI-SF) score from baseline(Up to 15 weeks)
- Change in Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) score from baseline(Up to 15 weeks)
- Patient Global Impression of Change (PGIC) score(Up to 15 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) score from baseline(Up to 15 weeks)
- Plasma ONO-1110 concentrations(Up to 15 weeks)
研究者
研究点 (52)
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