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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885430
First Posted: April 22, 2009
Last Update Posted: September 22, 2015
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.
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Further study details as provided by Dr. Lawrence Hookey, Queen's University:

Primary Outcome Measures:
  • serum electrolytes [ Time Frame: 48 hours ]
  • patient hemodynamics [ Time Frame: 48 hours ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Lawrence Hookey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00885430     History of Changes
Other Study ID Numbers: Hookey Pico-Salax Volunteers
First Submitted: April 20, 2009
First Posted: April 22, 2009
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Dr. Lawrence Hookey, Queen's University:
colonoscopy
preparation

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases