Text Size

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
History of Changes
  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:

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
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
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 May 23, 2013