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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Norgine BV

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