Patient Preference With Visicol Tablet Preparation for Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
InKine Pharmaceutical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00318305
First received: April 24, 2006
Last updated: December 1, 2009
Last verified: December 2009
  Purpose

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
Preparation for Colonoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 53
Study Start Date: March 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318305

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

No publications provided

Responsible Party: Suryakanth Gurudu, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00318305     History of Changes
Other Study ID Numbers: 392-05
Study First Received: April 24, 2006
Last Updated: December 1, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014