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

This study has been completed.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
First received: April 20, 2009
Last updated: September 18, 2015
Last verified: September 2015
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
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

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


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

Inclusion Criteria:

  • healthy volunteers older than 45

Exclusion Criteria:

  • impaired renal function
  • congestive heart failure ascites known electrolyte abnormalities
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00885430

Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L5G2
Sponsors and Collaborators
Queen's University
Ferring Pharmaceuticals
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 
Study First Received: April 20, 2009
Last Updated: September 18, 2015
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:

Additional relevant MeSH terms:
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on May 25, 2016