Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

This study has been completed.

First Received: April 20, 2009 Last Updated: April 21, 2009 History of Changes

Sponsors and Collaborators:	Queen's University Ferring Pharmaceuticals
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00885430

Purpose

Twenty adult volunteers will be administered Pico-Salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.

Condition	Intervention	Phase
Hemodynamics Hyponatremia	Drug: Pico-Salax	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

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 electrolytes [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
patient hemodynamics [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	July 2008
Study Completion Date:	September 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pico-Salax: Experimental	Drug: Pico-Salax Two sachets of Pico-Salax given 5 hours apart

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy volunteers older than 45

Exclusion Criteria:

impaired renal function
congestive heart failure ascites known electrolyte abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885430

Locations

Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L5G2

Sponsors and Collaborators

Queen's University

Ferring Pharmaceuticals

Investigators

Principal Investigator:

Lawrence Hookey, MD

Queen's University

More Information

No publications provided

Responsible Party:	Queen's University ( Lawrence Hookey, MD )
Study ID Numbers:	Hookey Pico-Salax Volunteers
Study First Received:	April 20, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00885430 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

colonoscopy
preparation

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on August 24, 2009