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Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
NCT00906217
First received: May 19, 2009
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

This study aims to further define the appropriate population for Pico-Salax, a purgative used prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and electrocardiograms (ECGs).


Condition
Colon Cleansing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • serum electrolyte changes pre and post preparation [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
elderly patients
patients older than 70 years with normal renal function

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients older than 70 scheduled for colonoscopy

Criteria

Inclusion Criteria:

  • >70 years

Exclusion Criteria:

  • renal dysfunction
  • congestive heart failure
  • ileus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906217

Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
  More Information

No publications provided

Responsible Party: Lawrence Hookey, assistant professor of medicine, Queen's University
ClinicalTrials.gov Identifier: NCT00906217     History of Changes
Other Study ID Numbers: Hookey Picosalax Elderly Trial
Study First Received: May 19, 2009
Last Updated: September 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
colonoscopy
preparation
safety
elderly

ClinicalTrials.gov processed this record on May 16, 2013