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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

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ClinicalTrials.gov Identifier: NCT01732692
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Collaborator:
Norgine BV
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Intervention Drug: MOVIPREP
Enrollment 140
Recruitment Details Participants took part in the study at 6 investigative sites in the Russian Federation and the Republic of Kazakhstan from 22 November 2012 to 5 April 2013.
Pre-assignment Details Participants indicated for a colonoscopy were enrolled equally in 1 of 2 treatment groups, morning-only on the day of the clinical procedure or split-dosing in 2 stages with a nocturnal pause.
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 70 70
Completed 70 69
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose) Total
Hide Arm/Group Description 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 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. Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
50.3  (17.41) 49.1  (16.26) 49.8  (16.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
38
  54.3%
55
  78.6%
93
  66.4%
Male
32
  45.7%
15
  21.4%
47
  33.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Asian 6 4 10
White 64 66 130
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 70 participants 70 participants 140 participants
171.1  (9.36) 165.1  (7.83) 168.1  (9.07)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 70 participants 70 participants 140 participants
73.5  (16.92) 68.3  (13.86) 71.1  (15.75)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 70 participants 70 participants 140 participants
25.1  (5.30) 25.1  (5.10) 25.1  (5.25)
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Russia 57 63 120
Kazakhstan 13 7 20
1.Primary Outcome
Title Percentage of Participants With Successful Colon Cleansing
Hide Description 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.
Time Frame 1 day (the day of colonoscopy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 70
Measure Type: Number
Unit of Measure: percentage of participants
94.29 91.43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MOVIPREP (Morning-only Dose), MOVIPREP (Split-dose)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) – control treatment group (split dose) was above a non-inferiority margin of -0.15%.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Exact Farrington - Manning
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 0.0286
Confidence Interval (1-Sided) 95%
-0.097
Estimation Comments Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control
2.Secondary Outcome
Title Patient Satisfaction of Colonoscopy Preparation (VAS)
Hide Description 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.
Time Frame 1 day (the day of colonoscopy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available VAS data.
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.2  (20.97) 79.6  (23.18)
3.Secondary Outcome
Title Total Compliance Score
Hide Description

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.

Time Frame 1 day (the day of colonoscopy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
98.1  (6.10) 99.5  (2.66)
4.Secondary Outcome
Title Patient Compliance – Amount of Additional Clear Liquid Consumed
Hide Description 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.
Time Frame 1 day (the day of colonoscopy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 69
Mean (Standard Deviation)
Unit of Measure: ml
After first liter of study drug 545.43  (128.6) 640.29  (243.4)
After second liter of study drug 539.71  (116.5) 585.65  (145.2)
5.Secondary Outcome
Title Percentage of Patients Who Experienced Adverse Events (AEs)
Hide Description 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.
Time Frame From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 70
Measure Type: Number
Unit of Measure: percentage of participants
Any adverse event (AE) 58.6 61.4
Mild adverse event 52.9 54.3
Moderate adverse event 5.7 7.1
Severe adverse event 0.0 0.0
Serious adverse event 0.0 0.0
AE leading to study discontinuation 0.0 1.4
Treatment-related adverse event 57.1 58.6
Time Frame From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Hide Arm/Group Description 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 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.
All-Cause Mortality
MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MOVIPREP (Morning-only Dose) MOVIPREP (Split-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   41/70 (58.57%)   43/70 (61.43%) 
Gastrointestinal disorders     
Abdominal discomfort  1  13/70 (18.57%)  26/70 (37.14%) 
Abdominal pain  1  1/70 (1.43%)  5/70 (7.14%) 
Abdominal tenderness  1  1/70 (1.43%)  2/70 (2.86%) 
Gastritis erosive  1  0/70 (0.00%)  1/70 (1.43%) 
Nausea  1  30/70 (42.86%)  22/70 (31.43%) 
Vomiting  1  5/70 (7.14%)  7/70 (10.00%) 
General disorders     
Product taste abnormal  1  0/70 (0.00%)  1/70 (1.43%) 
Pyrexia  1  0/70 (0.00%)  3/70 (4.29%) 
Infections and infestations     
Respiratory Tract Infection  1  0/70 (0.00%)  1/70 (1.43%) 
Investigations     
Alanine aminotransferase increased  1  3/70 (4.29%)  0/70 (0.00%) 
Aspartate aminotransferase increased  1  3/70 (4.29%)  0/70 (0.00%) 
Blood calcium decreased  1  0/70 (0.00%)  1/70 (1.43%) 
Blood calcium increased  1  1/70 (1.43%)  0/70 (0.00%) 
Blood chloride increased  1  1/70 (1.43%)  0/70 (0.00%) 
Blood creatinine increased  1  3/70 (4.29%)  1/70 (1.43%) 
Blood glucose increased  1  3/70 (4.29%)  0/70 (0.00%) 
Blood iron decreased  1  1/70 (1.43%)  5/70 (7.14%) 
Blood iron increased  1  2/70 (2.86%)  1/70 (1.43%) 
Body temperature increased  1  0/70 (0.00%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/70 (0.00%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01732692     History of Changes
Other Study ID Numbers: MV-9999-301-RU
U1111-1135-2011 ( Registry Identifier: WHO )
First Submitted: October 19, 2012
First Posted: November 26, 2012
Results First Submitted: April 5, 2014
Results First Posted: May 15, 2014
Last Update Posted: May 15, 2014