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
Study aim is to assess non-inferiority of the efficacy and to evaluate the tolerability and safety of experimental morning-only MOVIPREP® bowel preparation (full dose in the early morning of the colonoscopy procedure) in comparison with split-dose with nocturnal pause preparation (1/2 of dose in the evening before + 1/2 of dose in the morning of the colonoscopy procedure day).
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 (Caregiver)
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|
- To compare the percentage of patients on the morning only regimen arm who have a successful colon cleansing against the proportion of patients on the split dose arm who have a successful colon cleansing. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]Bowel cleansing defined by blinded endoscopist through visual evaluation of 5 colon segments will be summed up as success or failure. Quality of the cleansing classified on 4-level scale (A=success, all segments clean/all segments scored 4 or 3; B=success, at least 1 segment with remaining liquid/semi-solid amounts of stool, fully removable, at least 1 segment scored 2; C=failure, at least 1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D=failure, at least 1 segment with irremovable, heavy, hard stools, at least 1 segment scored 0).
- Patient satisfaction of colonoscopy preparation based on verbal response scale (VRS) and visual analogous scale (VAS). [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]Patient satisfaction will be measured on a 4-level verbal response scale which has the following grades - very good, good, acceptable, and unacceptable. Based on a patient mark placed in VRS a patient satisfaction of colonoscopy preparation will be measured.
- Patient satisfaction of colonoscopy preparation (VAS) [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]Patient satisfaction measured on VAS. The VAS is 100 mm long and positioned horizontally. VAS starts from score 0 (Totally unacceptable) which reflects the lowest patient satisfaction of colonoscopy preparation and finishes with the score 100 (Fully acceptable) which shows the highest patient satisfaction with the procedure. Based on a patient mark placed on the VAS a patient satisfaction of colonoscopy preparation will be measured. If the mark is closer to score 0, the less patient satisfaction is and vice versa the mark closer to score 100 means the better patient satisfaction.
- Patient compliance to the treatment. The patient's adherence to a recommended volume of MOVIPREP® to be taken for successful bowel preparation. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]Amount of Moviprep solution consumed in Litres.
- Patient compliance - additional clear liquid consumed. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]Amount of additional clear liquid consumed in Litres. To prevent any potential dehydration risk the patients are recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the MOVIPREP® solution.
- Percentage of patients who experience each treatment-emergent adverse event reported by ≥5% of patients during the study. [ Time Frame: Per Incidence (until the end of colonoscopy procedure) ] [ Designated as safety issue: Yes ]A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug (AE start date ≥ first dose date) and until the end of colonoscopy procedure (AE start date - last dose date ≤ the colonoscopy procedure).
|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 subjects 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 of the late morning or afternoon colonoscopy clinical procedure. Patients of 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 morning or afternoon colonoscopy clinical procedure.
The study consists of three visits:
visit 1 /screening visit 2 /baseline visit 3 /day of colonoscopy
The participation of a patient 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 AEs when the follow-up period will last until the subject has recovered or until all AE-related queries for the subject have been resolved.
|Alma Ata, Kazakhstan|
|Moscow, Russian Federation|
|Saint-Petersburg, Russian Federation|
|Saint-Petersburg,, Russian Federation|
|Study Director:||Study Director||Nycomed: A Takeda Company|