Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation

Phase 3

Completed

Conditions: Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.

Interventions: Drug: MOVIPREP

Registration Number: NCT01732692

Lead Sponsor: Takeda

Brief Summary: To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

ileus
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOVIPREP (Morning-only dose)	MOVIPREP	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.
MOVIPREP (Split-dose)	MOVIPREP	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Successful Colon Cleansing	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.

Secondary Outcome Measures

Name	Time	Method
Total Compliance Score	1 day (the day of colonoscopy)	Compliance score = 100 \* (total amount MOVIPREP® intake) / (planned MOVIPREP intake). Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.
Percentage of Patients Who Experienced Adverse Events (AEs)	From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.	An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.
Patient Satisfaction of Colonoscopy Preparation (VAS)	1 day (the day of colonoscopy)	Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.
Patient Compliance - Amount of Additional Clear Liquid Consumed	1 day (the day of colonoscopy)	To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.