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

April 20, 2009
November 2, 2009
July 2008
July 2008   (final data collection date for primary outcome measure)
  • serum electrolytes [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • patient hemodynamics [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Hemodynamics
  • Hyponatremia
Drug: Pico-Salax
Two sachets of Pico-Salax given 5 hours apart
Experimental: Pico-Salax
Intervention: Drug: Pico-Salax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers older than 45

Exclusion Criteria:

  • impaired renal function
  • congestive heart failure ascites known electrolyte abnormalities
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00885430
Hookey Pico-Salax Volunteers
No
Lawrence Hookey, MD, Queen's University
Queen's University
Ferring Pharmaceuticals
Principal Investigator: Lawrence Hookey, MD Queen's University
Queen's University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP