Patient Preference With Visicol Tablet Preparation for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318305
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : December 2, 2009
InKine Pharmaceutical
Information provided by:
Mayo Clinic

Brief Summary:
The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.

Condition or disease
Preparation for Colonoscopy

Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study
Study Start Date : March 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Scheduled colonoscopy list will be reviewed to identify potential subjects for recruitment. A cover letter will be sent to the potential study subject with tablet preparation as an alternative to Golytely preparation ( PEG). For subjects who are willing to participate, a prescription for 28 tablet sodium phosphate bowel preparation as outlined in appendix: A will be mailed. A questionnaire will be given to the patients prior to their colonoscopy to identify their preferences regarding bowel preparation and their acceptance ( see appendix: B).

A separate validated questionnaire will be given to participating physicians after the procedure, to quantitate the colonic cleansing (appendix : C). Adverse events will be documented. A statistical analysis of the results will be done at the end of the study.


Inclusion Criteria:

  • Prior colonoscopy with PEG solution in the past one year
  • Must be able to swallow tablets

Exclusion Criteria:

  • Patients below 18 years and above 100 years.
  • Congestive heart failure
  • Chronic renal failure
  • Pre-existing electrolyte disorder
  • Pre-existing mega-colon or a motility disorder.
  • Patients with pre-existing seizure disorder.
  • Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study.
  • Pregnant or lactating women

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 identifier (NCT number): NCT00318305

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
InKine Pharmaceutical
Principal Investigator: Suryakanth R. Gurudu, M.D. Mayo Clinic

Responsible Party: Suryakanth Gurudu, MD, Mayo Clinic Identifier: NCT00318305     History of Changes
Other Study ID Numbers: 392-05
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009