NCT06752603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 Hunner Type Interstitial Cystitis
Ono Pharmaceutical Co., Ltd.36 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年4月2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
- 57
- 试验地点
- 36
- 主要终点
- Change in weekly mean of average pain score from baseline to Week 12 of the treatment period
研究概览
简要总结
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Hunner Type Interstitial Cystitis
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 who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator）
- •Patients given a diagnosis of HIC by cystoscopy
- •Patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria
排除标准
- •Patients with a history and presence of chemical cystitis
- •Patients with a history of bladder augmentation or radical cystectomy
- •Patients with pain other than HIC 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 receiving medications for psychiatric disease
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 from baseline to Week 12 of the treatment period
时间窗: Up to 20 weeks
Adverse events
时间窗: Up to 20 weeks
次要结局
- Change in weekly mean of average pain score from baseline in each week(Up to 20 weeks)
- Change in Average frequency of urination per day from baseline(Up to 20 weeks)
- 30%- and 50%-responder rates based on the weekly mean of average pain score(Up to 20 weeks)
- Change in weekly mean of worst pain score from baseline to each week(Up to 20 weeks)
- 30%- and 50%-responder rates based on the weekly mean of worst pain score(Up to 20 weeks)
- Change in Interstitial cystitis symptom index (ICSI) score from baseline(Up to 20 weeks)
- Change in Interstitial cystitis problem index (ICPI) score from baseline(Up to 20 weeks)
- Change in Frequency of nocturnal urination per day from baseline(Up to 20 weeks)
- Change in Mean volume voided per micturition in a day from baseline(Up to 20 weeks)
- Change in Maximum volume voided per micturition in a day from baseline(Up to 20 weeks)
- Change in Number of urgency episodes per day from baseline(Up to 20 weeks)
- Change in Patient Global Impression of Change (PGIC) score from baseline(Up to 20 weeks)
- Change in SF-12v2 score from baseline(Up to 20 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) score from baseline(Up to 20 weeks)
- Plasma ONO-1110 concentrations(Up to 20 weeks)
研究者
研究点 (36)
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