A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 364
- 试验地点
- 60
- 主要终点
- The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
研究概览
简要总结
The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.
详细描述
In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.
The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.
Adult subjects (≥18 to <65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).
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
- •Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
- •Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
- •Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas].
排除标准
- •Subjects in whom constipation is thought to be drug-induced
- •Subjects using any disallowed medication.
- •Subjects who previously used prucalopride.
- •Subjects suffering from secondary causes of chronic constipation.
研究组 & 干预措施
Placebo
Placebo 2 mg tablet once daily before breakfast
干预措施: placebo (Drug)
prucalopride
Prucalopride 2 mg once daily before breakfast
干预措施: prucalopride (Drug)
结局指标
主要结局
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period
时间窗: Over 24 week treatment period
Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
次要结局
- Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks(Over 24 week treatment period)
- Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks(Over 24 week treatment period)
- Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value(Baseline and Over 24 week treatment period)
- Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week(Over 24 week treatment period)
- Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period(Over 24 week treatment period)
- Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in Straining Per SCBM at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Time to First SCBM After Investigational Product Intake on Day 1 and Day 28(Day 1 and 28)
- Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks(Baseline and Over 24 week treatment period)
- Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value(Baseline and Over 24 week treatment period)
- Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value(Baseline and Over 24 week treatment period)