Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 主要终点
- Percentage of Participants With Successful Colon Cleansing
研究概览
简要总结
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
详细描述
All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.
The study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum.
There is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female ≥18 years and ≤ 85 years
- •colonoscopy procedure indicated
- •willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion
- •willing and able to undergo study-related procedures
- •informed consent signed by a patient for participation in the study
- •negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study
排除标准
- •suspected colonic tumor with manifestations of intestinal obstruction
- •delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation
- •toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis
- •suspected intestinal perforation or risk of gastrointestinal perforation
- •signs of severe intestinal bleeding
- •acute inflammatory anal or perianal pathology
- •severe concomitant diseases of internal organs
- •psychiatric diseases in aggravation stage
- •hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation
- •phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency
- •unconsciousness
- •dehydration
- •severe inflammatory diseases
- •acute abdominal pain of unknown etiology
- •pregnancy and lactation period
- •participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial
- •patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)
- •any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data
研究组 & 干预措施
MOVIPREP (Morning-only dose)
MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
干预措施: MOVIPREP (Drug)
MOVIPREP (Split-dose)
MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
干预措施: MOVIPREP (Drug)
结局指标
主要结局
Percentage of Participants With Successful Colon Cleansing
时间窗: 1 day (the day of colonoscopy)
Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.
次要结局
- Total Compliance Score(1 day (the day of colonoscopy))
- Percentage of Patients Who Experienced Adverse Events (AEs)(From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.)
- Patient Satisfaction of Colonoscopy Preparation (VAS)(1 day (the day of colonoscopy))
- Patient Compliance - Amount of Additional Clear Liquid Consumed(1 day (the day of colonoscopy))