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

NCT ID: NCT01732692

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MOVIPREP

Intervention Type: DRUG

MOVIPREP solution

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.

Group Type: OTHER

MOVIPREP

Intervention Type: DRUG

MOVIPREP solution

Interventions

MOVIPREP

MOVIPREP solution

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine BV

UNKNOWN

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Almaty, , Kazakhstan

Moscow, , Russia

Saint Petersburg, , Russia

Countries

Kazakhstan; Russia

Other Identifiers

U1111-1135-2011

Identifier Type: REGISTRY

Identifier Source: secondary_id

MV-9999-301-RU

Identifier Type: -

Identifier Source: org_study_id