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: June 6, 2013
Last verified: June 2013
  Purpose

Study aim is to assess non-inferiority of the efficacy and to evaluate the tolerability and safety of experimental morning-only MOVIPREP® bowel preparation (full dose in the early morning of the colonoscopy procedure) in comparison with split-dose with nocturnal pause preparation (1/2 of dose in the evening before + 1/2 of dose in the morning of the colonoscopy procedure day).


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 (Caregiver)
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:
  • To compare the percentage of patients on the morning only regimen arm who have a successful colon cleansing against the proportion of patients on the split dose arm who have a successful colon cleansing. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Bowel cleansing defined by blinded endoscopist through visual evaluation of 5 colon segments will be summed up as success or failure. Quality of the cleansing classified on 4-level scale (A=success, all segments clean/all segments scored 4 or 3; B=success, at least 1 segment with remaining liquid/semi-solid amounts of stool, fully removable, at least 1 segment scored 2; C=failure, at least 1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D=failure, at least 1 segment with irremovable, heavy, hard stools, at least 1 segment scored 0).


Secondary Outcome Measures:
  • Patient satisfaction of colonoscopy preparation based on verbal response scale (VRS) and visual analogous scale (VAS). [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Patient satisfaction will be measured on a 4-level verbal response scale which has the following grades - very good, good, acceptable, and unacceptable. Based on a patient mark placed in VRS a patient satisfaction of colonoscopy preparation will be measured.

  • Patient satisfaction of colonoscopy preparation (VAS) [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Patient satisfaction measured on VAS. The VAS is 100 mm long and positioned horizontally. VAS starts from score 0 (Totally unacceptable) which reflects the lowest patient satisfaction of colonoscopy preparation and finishes with the score 100 (Fully acceptable) which shows the highest patient satisfaction with the procedure. Based on a patient mark placed on the VAS a patient satisfaction of colonoscopy preparation will be measured. If the mark is closer to score 0, the less patient satisfaction is and vice versa the mark closer to score 100 means the better patient satisfaction.

  • Patient compliance to the treatment. The patient's adherence to a recommended volume of MOVIPREP® to be taken for successful bowel preparation. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Amount of Moviprep solution consumed in Litres.

  • Patient compliance - additional clear liquid consumed. [ Time Frame: 1 day (the day of colonoscopy) ] [ Designated as safety issue: No ]
    Amount of additional clear liquid consumed in Litres. To prevent any potential dehydration risk the patients are recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the MOVIPREP® solution.

  • Percentage of patients who experience each treatment-emergent adverse event reported by ≥5% of patients during the study. [ Time Frame: Per Incidence (until the end of colonoscopy procedure) ] [ Designated as safety issue: Yes ]
    A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug (AE start date ≥ first dose date) and until the end of colonoscopy procedure (AE start date - last dose date ≤ the colonoscopy procedure).


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 subjects 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 of the late morning or afternoon colonoscopy clinical procedure. Patients of 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 morning or afternoon colonoscopy clinical procedure.

The study consists of three visits:

visit 1 /screening visit 2 /baseline visit 3 /day of colonoscopy

The participation of a patient 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 AEs when the follow-up period will last until the subject has recovered or until all AE-related queries for the subject 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 subjects in the age ≥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 HIV/AID, RW or HBC
  • any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data
  Contacts and Locations
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: Study Director 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
Last Updated: June 6, 2013
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 April 17, 2014