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
Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Percentage of Participants With Successful Colon Cleansing [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]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.
- Patient Satisfaction of Colonoscopy Preparation (VAS) [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]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.
- Total Compliance Score [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
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.
- Patient Compliance - Amount of Additional Clear Liquid Consumed [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]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.
- Percentage of Patients Who Experienced Adverse Events (AEs) [ Time Frame: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732692
|Alma Ata, Kazakhstan|
|Moscow, Russian Federation|
|Saint-Petersburg,, Russian Federation|
|Saint-Petersburg, Russian Federation|
|Study Director:||Medical Director Clinical Science||Takeda|