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

This study has been completed.
Sponsor:
Collaborator:
Norgine BV
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01732692
First received: October 19, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Drug: MOVIPREP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants With Successful Colon Cleansing [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Satisfaction of Colonoscopy Preparation (VAS) [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.

  • Total Compliance Score [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]

    Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).

    Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.


  • Patient Compliance - Amount of Additional Clear Liquid Consumed [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.

  • Percentage of Patients Who Experienced Adverse Events (AEs) [ Time Frame: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. ] [ Designated as safety issue: Yes ]
    An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.


Enrollment: 140
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: MOVIPREP
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.
Drug: MOVIPREP
MOVIPREP solution

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732692

Locations
Kazakhstan
Alma Ata, Kazakhstan
Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Saint-Petersburg,, Russian Federation
Sponsors and Collaborators
Takeda
Norgine BV
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01732692     History of Changes
Other Study ID Numbers: MV-9999-301-RU, U1111-1135-2011
Study First Received: October 19, 2012
Results First Received: April 5, 2014
Last Updated: April 16, 2014
Health Authority: Russian Federation: The Ministry of Healthcare of the Russian Federation
Republic of Kazakhstan: The Ministry of Healthcare of the Republic of Kazakhstan

Keywords provided by Takeda:
Bowel preparation, MOVIPREP®

ClinicalTrials.gov processed this record on October 21, 2014