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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732692
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Norgine BV
Information provided by (Responsible Party):

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: MoviPrep

Arm Intervention/treatment
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.
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.
MOVIPREP solution

Primary Outcome Measures :
  1. Percentage of Participants With Successful Colon Cleansing [ Time Frame: 1 day (the day of colonoscopy) ]
    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 :
  1. Patient Satisfaction of Colonoscopy Preparation (VAS) [ Time Frame: 1 day (the day of colonoscopy) ]
    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.

  2. Total Compliance Score [ Time Frame: 1 day (the day of colonoscopy) ]

    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.

  3. Patient Compliance - Amount of Additional Clear Liquid Consumed [ Time Frame: 1 day (the day of colonoscopy) ]
    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.

  4. 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. ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732692

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Alma Ata, Kazakhstan
Russian Federation
Moscow, Russian Federation
Saint-Petersburg,, Russian Federation
Saint-Petersburg, Russian Federation
Sponsors and Collaborators
Norgine BV
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda Identifier: NCT01732692    
Other Study ID Numbers: MV-9999-301-RU
U1111-1135-2011 ( Registry Identifier: WHO )
First Posted: November 26, 2012    Key Record Dates
Results First Posted: May 15, 2014
Last Update Posted: May 15, 2014
Last Verified: April 2014
Keywords provided by Takeda:
Bowel preparation, MOVIPREP®