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

Takeda

Status and phase: Completed; Phase 3

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

Treatments: Drug: MOVIPREP

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01732692

U1111-1135-2011 (Registry Identifier)

MV-9999-301-RU

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

MOVIPREP (Morning-only dose)

Experimental group

Description:

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.

Treatment:

Drug: MOVIPREP

MOVIPREP (Split-dose)

Other group

Description:

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.

Treatment:

Drug: MOVIPREP