Back to resultsTrial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
bowel prep before endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Bowel prep, Safety, Efficacy
Eligibility Criteria
Inclusion Criteria:
- Patients suspected of colorectal cancer scheduled for colonoscopy
Exclusion Criteria:
- Patients with previous colorectal surgery
- Colonis Stenosis
- ASA > 2
Sites / Locations
- Randers Regions Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Moviprep
Phosphoral
Arm Description
Moviprep bowel preb
Bowel prep
Outcomes
Primary Outcome Measures
Degree of bowel cleansing
Will be estimated by the patients and the colonoscopist
Secondary Outcome Measures
Full Information
NCT ID
NCT01519609
First Posted
September 16, 2011
Last Updated
November 20, 2012
Sponsor
Randers Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01519609
Brief Title
Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy
Official Title
Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Randers Regional Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Bowel prep, Safety, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moviprep
Arm Type
Active Comparator
Arm Description
Moviprep bowel preb
Arm Title
Phosphoral
Arm Type
Active Comparator
Arm Description
Bowel prep
Intervention Type
Drug
Intervention Name(s)
bowel prep before endoscopy
Intervention Description
bowel prep before colonoscopy
Primary Outcome Measure Information:
Title
Degree of bowel cleansing
Description
Will be estimated by the patients and the colonoscopist
Time Frame
1 Day of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suspected of colorectal cancer scheduled for colonoscopy
Exclusion Criteria:
Patients with previous colorectal surgery
Colonis Stenosis
ASA > 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
thorbjorn sommer, ph.D
Organizational Affiliation
unaffilated
Official's Role
Study Director
Facility Information:
Facility Name
Randers Regions Hospital
City
Randers
ZIP/Postal Code
8970
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy
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