NCT00318305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

April 24, 2006

Last Update Submit

December 1, 2009

Conditions

Preparation for Colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Study Officials

  • Suryakanth R. Gurudu, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

March 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

US(1)