NCT00885430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

April 20, 2009

Last Update Submit

September 18, 2015

Conditions

HemodynamicsHyponatremia

Keywords

colonoscopypreparation

Outcome Measures

Primary Outcomes (2)

  • serum electrolytes

    48 hours

  • patient hemodynamics

    48 hours

Study Arms (1)

Pico-Salax

EXPERIMENTAL
Drug: Pico-Salax

Interventions

Pico-SalaxDRUG

Two sachets of Pico-Salax given 5 hours apart

Pico-Salax

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers older than 45

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

Pico-Salax

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lawrence Hookey, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

CA(1)