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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00885430
First received: April 20, 2009
Last updated: November 2, 2009
Last verified: November 2009
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

Resource links provided by NLM:


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
Experimental: Pico-Salax 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
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: 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: Lawrence Hookey, MD, Queen's University
ClinicalTrials.gov Identifier: NCT00885430     History of Changes
Other Study ID Numbers: Hookey Pico-Salax Volunteers
Study First Received: April 20, 2009
Last Updated: November 2, 2009
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
colonoscopy
preparation

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

ClinicalTrials.gov processed this record on August 27, 2014