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

Primary Purpose

Hemodynamics, Hyponatremia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pico-Salax
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemodynamics focused on measuring colonoscopy, preparation

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers older than 45

Exclusion Criteria:

  • impaired renal function
  • congestive heart failure ascites known electrolyte abnormalities

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pico-Salax

Arm Description

Outcomes

Primary Outcome Measures

serum electrolytes
patient hemodynamics

Secondary Outcome Measures

Full Information

First Posted
April 20, 2009
Last Updated
September 18, 2015
Sponsor
Queen's University
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00885430
Brief Title
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Official Title
Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamics, Hyponatremia
Keywords
colonoscopy, preparation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pico-Salax
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pico-Salax
Intervention Description
Two sachets of Pico-Salax given 5 hours apart
Primary Outcome Measure Information:
Title
serum electrolytes
Time Frame
48 hours
Title
patient hemodynamics
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers older than 45 Exclusion Criteria: impaired renal function congestive heart failure ascites known electrolyte abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Hookey, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L5G2
Country
Canada

12. IPD Sharing Statement

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

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