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

NCT01732692 | Completed Phase 3 Results

• 2 other identifiers: MV-9999-301-RUU1111-1135-2011
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Bowel preparation, MOVIPREP®

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Colon Cleansing

  Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.

  1 day (the day of colonoscopy)

Secondary Outcomes (4)

• Patient Satisfaction of Colonoscopy Preparation (VAS)

  1 day (the day of colonoscopy)

• Total Compliance Score

  1 day (the day of colonoscopy)

• Patient Compliance - Amount of Additional Clear Liquid Consumed

  1 day (the day of colonoscopy)

• Percentage of Patients Who Experienced Adverse Events (AEs)

  From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.

Study Arms (2)

MOVIPREP (Morning-only dose)

EXPERIMENTAL

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.

Drug: MOVIPREP

MOVIPREP (Split-dose)

OTHER

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.

Drug: MOVIPREP

Interventions

MOVIPREP DRUG

MOVIPREP solution

MOVIPREP (Morning-only dose); MOVIPREP (Split-dose)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda: lead
• Norgine BV: collaborator

Study Sites (3)

Unknown Facility

Alma-Ata, Kazakhstan

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

MeSH Terms

Interventions

MoviPrep

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: November 26, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 15, 2014
• Results First Posted: May 15, 2014

Record last verified: 2014-04

Locations

KA (1); RU (2)