NCT06752590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 Fibromyalgia
Ono Pharmaceutical Co., Ltd.49 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2025年3月26日最近更新:
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
- 175
- 试验地点
- 49
- 主要终点
- Change in weekly mean of average pain score 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 Patients with Fibromyalgia
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)
- •Outpatient
- •Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
- •Patients who meet the American College of Rheumatology Fibromyalgia Criteria
排除标准
- •Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease
- •Patients with pain other than FM 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 a past history of or concurrent malignant tumor within 3 years
- •Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.
研究组 & 干预措施
ONO-1110
Experimental
ONO-1110 tablets once a day
干预措施: ONO-1110 (Drug)
Placebo
Placebo Comparator
Placebo tablets once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
时间窗: Up to 16 weeks
Adverse events
时间窗: Up to 16 weeks
次要结局
- Change in weekly mean of average pain score from baseline in each week(Up to 16 weeks)
- 30%- and 50%-responder rates based on the weekly mean of average pain score(Up to 16 weeks)
- Change in weekly mean of worst pain score from baseline to each week(Up to 16 weeks)
- 30%- and 50%-responder rates based on the weekly mean of worst pain score(Up to 16 weeks)
- Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline(Up to 16 weeks)
- Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline(Up to 16 weeks)
- Change in Patient Global Impression of Change (PGIC) score from baseline(Up to 16 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) score from baseline(Up to 16 weeks)
- Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline(Up to 16 weeks)
- Plasma ONO-1110 concentrations(Up to 16 weeks)
研究者
研究点 (49)
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