Clinical trial NCT01732692: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Keywords: Bowel preparation, MOVIPREP®
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Norgine BV
First posted: 2012-11-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Successful Colon Cleansing
timeFrame: 1 day (the day of colonoscopy)
Secondary outcomes:
measure: Patient Satisfaction of Colonoscopy Preparation (VAS)
timeFrame: 1 day (the day of colonoscopy)
measure: Total Compliance Score
timeFrame: 1 day (the day of colonoscopy)
measure: Patient Compliance - Amount of Additional Clear Liquid Consumed
timeFrame: 1 day (the day of colonoscopy)
measure: Percentage of Patients Who Experienced Adverse Events (AEs)
timeFrame: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.
Other outcomes:
Locations:
city: Alma Ata
country: Kazakhstan
city: Moscow
country: Russian Federation
city: Saint-Petersburg,
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: