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

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ClinicalTrials.gov Identifier: NCT00618930
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cleansing Prior Operation Drug: Moviprep® Drug: Fleet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : February 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: MoviPrep
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Moviprep®
use of Moviprep®
Active Comparator: 2
Use of Fleet
Drug: Fleet
Use of Fleet



Primary Outcome Measures :
  1. colorectal cleansing [ Time Frame: prior operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618930


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent

Additional Information:
Responsible Party: Piet Pattyn, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00618930     History of Changes
Other Study ID Numbers: 2007/320
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Laxatives
Gastrointestinal Agents