Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation

This study has been completed.

First Received on February 6, 2008. Last Updated on April 14, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00618930

Purpose

The patients are assigned by randomisation on one of the two laxatives. After cleansing they have to fill in an evaluation form to report their findings and difficulties. Also the surgeon will be asked to fill in a score-form to report all details concerning the bowel preparation.

Condition	Intervention	Phase
Colorectal Cleansing Prior Operation	Drug: Moviprep® Drug: Fleet	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation.

Resource links provided by NLM:

Drug Information available for: Sodium phosphate, dibasic Pramocaine Pramoxine hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

colorectal cleansing [ Time Frame: prior operation ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Moviprep® use of Moviprep®
Active Comparator: 2 Use of Fleet	Drug: Fleet Use of Fleet

Eligibility

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

Criteria

Inclusion Criteria:

Men and women
Older than 18
Informed consent signed
Mode of surgery

Exclusion Criteria:

Renal disease
Heart failure
Dehydration
Abdominal obstruction
Abdominal perforation
Abdominal paralysis
Toxic megacolon

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618930

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Piet Pattyn, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00618930 History of Changes
Other Study ID Numbers:	2007/320
Study First Received:	February 6, 2008
Last Updated:	April 14, 2009
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Laxatives
Pramoxine
Sodium phosphate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Cathartics

ClinicalTrials.gov processed this record on February 09, 2012