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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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 (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.

Participant Flow:   Overall Study
    MOVIPREP (Morning-only Dose)   MOVIPREP (Split-dose)
STARTED   70   70 
COMPLETED   70   69 
NOT COMPLETED   0   1 
Adverse Event                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 (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.
Total Total of all reporting groups

Baseline Measures
   MOVIPREP (Morning-only Dose)   MOVIPREP (Split-dose)   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.3  (17.41)   49.1  (16.26)   49.8  (16.79) 
Gender 
[Units: Participants]
     
Female   38   55   93 
Male   32   15   47 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   6   4   10 
White   64   66   130 
Height 
[Units: Cm]
Mean (Standard Deviation)
 171.1  (9.36)   165.1  (7.83)   168.1  (9.07) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 73.5  (16.92)   68.3  (13.86)   71.1  (15.75) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.1  (5.30)   25.1  (5.10)   25.1  (5.25) 
Region of Enrollment 
[Units: Participants]
     
Russia   57   63   120 
Kazakhstan   13   7   20 


  Outcome Measures

1.  Primary:   Percentage of Participants With Successful Colon Cleansing   [ Time Frame: 1 day (the day of colonoscopy) ]

2.  Secondary:   Patient Satisfaction of Colonoscopy Preparation (VAS)   [ Time Frame: 1 day (the day of colonoscopy) ]

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

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

5.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



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