A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 507
- 主要终点
- Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movements (SCBMs)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of prucalopride to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in treatment of participants with chronic (very serious, life threatening) constipation (decreased number of or difficulty making bowel [the intestine] movements).
详细描述
This is a randomized (study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participants receives), placebo-controlled, multi-center (when more than 1 hospital or medical school team work on a medical research study) study with a parallel-group design (a medical research study comparing the response in 2 or more groups of participants receiving different treatments) study of prucalopride. This study consist of 3 phases: a 2 weeks drug-free screening or run in phase, a 12-week treatment phase and follow-up (post-treatment) phase performed 7 days following the last dose of study drug. The total duration of study will be approximately 15 to 20 weeks, including the run-in and post-treatment phases. During the run-in phase, participants will receive laxative (bisacodyl) as a rescue medication throughout the study, if they will not have bowel movement (BM) for 3 or more consecutive days. If participants will not be able to tolerate bisacodyl, an enema may be used in place of the bisacodyl. During the double-blind treatment phase, participants will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups to receive either 2 milligram (mg) prucalopride or matching placebo prucalopride for 12 weeks, orally once daily. Participants will be primarily assessed for spontaneous complete bowel movements (SCBMs) per week. Participant's safety and quality of life will be monitored throughout the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chronic constipation, defined as on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for at least a quarter of the time for the last 3 months, while symptom onset was more than 6 months before the screening visit: in more than 25 percent (%) of BMs, participants had very hard (little balls) and/or hard stools, sensation of incomplete evacuation, straining at defecation (making a bowel movement), sensation of ano-rectal obstruction or blockade, and/or need for digital manipulation to facilitate evacuation
- •Participants who were considered as constipated (who never had SBMs)
- •Participant's constipation is functional
- •Participants with the diagnosis of irritable bowel syndrome (bowel disorder in which there is pain and diarrhea or constipation) with constipation and with no other organic diseases can potentially be included depending on the decision of the investigator
- •Female participants must be postmenopausal (for at least 1 year) or surgically sterile or practicing a highly effective method of birth control
排除标准
- •Secondary to other diseases/conditions (endocrine disorders, metabolic disorders or neurologic disorders or drug-induced or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma (type of cancer), or inflammatory bowel disease)
- •- Participants Using or intending to use disallowed medications that may influence the bowel habit during the study
- •Participants with severe (very serious, life threatening) and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer (abnormal tissue that grows and spreads in the body until it kills) or acquired immune deficiency syndrome (AIDS: illness that results in decreased ability of the body to protect itself from other illnesses; development of the disease or conditions associated with the disease results from Human Immunodeficiency Virus [HIV]), or other gastrointestinal or endocrine disorders
- •Participants with impaired renal function, that is, serum creatinine greater than 2 milligram per deciliter (greater than 180 micro mole per liter)
- •Participants with clinically significant abnormalities of hematology, urinalysis, or blood chemistry
研究组 & 干预措施
Prucalopride
prucalopride 2- milligram (mg), orally once daily for 12 weeks
干预措施: Prucalopride (Drug)
Placebo
Matching placebo, orally once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movements (SCBMs)
时间窗: Week 1 to 12
Percentage of responders (responders: participants with an average of 3 or more SCBMs per week) will be assessed during 12-week double-blind treatment phase (total treatment duration). SCBM is defined as a Spontaneous Bowel Movement (SBM) associated with a sense of complete evacuation. SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository used on either the calendar day of the BM or the calendar day before the BM. The total number of SBMs associated with a feeling of complete evacuation will be summed and divided by 12. Average weekly frequency of SCBMs will be calculated as number of SCBMs in treatment phase multiplied by 7 divided by total number of evaluable days in treatment phase.
次要结局
- Average Number of Bisacodyl Tablets(Week 1 to 12)
- Percentage of BMs With Normal Consistency(Week 1 to 12)
- Percentage of BMs With Less Straining(Week 1 to 12)
- Average Number of SCBMs(Week 1 to 12)
- Time-to-First SCBM and Time-to-First Week With 3 or More SCBMs After the First Dose of the Study Drug(Week 1 to 12)
- Percentage of Participants With Zero, Less Than (<) 2 and Greater Than and Equal to (>=) 2 Tablets of Bisacodyl Taken(Week 1 to 12)
- Percentage of Participants With an Average of 3 or More SCBMs During the First 4 Weeks(Week 1 to 4)
- Percentage of Participants With an Average of 3 or More SCBMs During Weeks 5 to 8 and 9 to 12(Week 5 to Week 8 and Week 9 to Week 12)
- Percentage of Participants With an Average Increase of 1 or More Bowel Movements (BMs)(Week 1 to 12)
- Average Number of Spontaneous Bowel Movements (SBMs)(Week 1 to 12)
- Average Number of all Bowel Movements (BMs)(Week 1 to 12)
- Percentage of BMs with a Sensation of Complete Evacuation(Week 1 to 12)
- Participants Global Assessment on Consistency of Stool(Week 2, 4, 8 and 12)
- Participants Global Assessment on Severity of Constipation(Week 2, Week 4, Week 8 and Week 12)
- Participants Global Assessment on Efficacy of Treatment(Week 2, Week 4, Week 8, and Week 12)
- Investigator's Global Assessment on Efficacy of Treatment(Week 4 and 12)
- Change From Baseline in Patient Assessment of Constipation-Symptom Questionnaire (PAC-SYM) Total Score at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, and 12)
- Change From Baseline in the PAC-SYM Subscale Scores at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, and 12)
- Percentage of Participant's who Rated Study Drug effectiveness(Week 2, Week 4, Week 8 and Week 12)
- Percentage of Participants With PAC SYM Score(Weeks 2, 4, 8, and 12)