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Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thorbjorn Sommer, Randers Region Hospital
ClinicalTrials.gov Identifier:
NCT01519609
First received: September 16, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Drug: bowel prep before endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Randers Region Hospital:

Primary Outcome Measures:
  • Degree of bowel cleansing [ Time Frame: 1 Day of colonoscopy ] [ Designated as safety issue: No ]
    Will be estimated by the patients and the colonoscopist


Enrollment: 400
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moviprep
Moviprep bowel preb
 Drug: bowel prep before endoscopy
bowel prep before colonoscopy
Active Comparator: Phosphoral
Bowel prep
 Drug: bowel prep before endoscopy
bowel prep before colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suspected of colorectal cancer scheduled for colonoscopy

Exclusion Criteria:

  • Patients with previous colorectal surgery
  • Colonis Stenosis
  • ASA > 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519609

Locations
Denmark
Randers Regions Hospital
Randers, Denmark, 8970
Sponsors and Collaborators
Randers Region Hospital
Investigators
Study Director: thorbjorn sommer, ph.D unaffilated
  More Information

No publications provided

Responsible Party: Thorbjorn Sommer, M.D, Ph.D Associate Professor, Randers Region Hospital
ClinicalTrials.gov Identifier: NCT01519609     History of Changes
Other Study ID Numbers: Randers-Moviprep
Study First Received: September 16, 2011
Last Updated: November 20, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Randers Region Hospital:
Bowel prep
Safety
Efficacy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013