Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy

Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: bowel prep before endoscopy

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Randers, Denmark, 8970
    • Randers regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients suspected of colorectal cancer scheduled for colonoscopy

Exclusion Criteria:

• Patients with previous colorectal surgery
• Colonis Stenosis
• ASA > 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of bowel cleansing	Will be estimated by the patients and the colonoscopist	1 Day of colonoscopy

Collaborators and Investigators

• Sponsor: Randers Regional Hospital
• Investigators: Study Director: thorbjorn sommer, ph.D, Unaffilated

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Bowel prep
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Randers-Moviprep