NCT00885274

Brief Summary

Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2008

Typical duration 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

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

April 20, 2009

Last Update Submit

August 27, 2015

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • bowel cleansing assessed by the Ottawa Bowel Preparation Scale

    day of colonoscopy

Secondary Outcomes (1)

  • patient tolerance of preparation

    day of colonoscopy

Study Arms (2)

Split Dose

EXPERIMENTAL

Doses of Pico-Salax split: one dose administered the night prior to colonoscopy and the other dose administered the day of the procedure.

Drug: Split Dose Pico-Salax

Traditional Dose

ACTIVE COMPARATOR

Both doses of Pico-Salax taken the evening prior to colonoscopy.

Drug: Pico-Salax

Interventions

Pico-SalaxDRUG

Both doses of Pico-Salax taken the evening prior to colonoscopy

Traditional Dose
Split Dose Pico-SalaxDRUG

One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.

Split Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colonoscopy indicated

You may not qualify if:

  • congestive heart failure
  • ascites
  • renal failure
  • hyponatremia
  • previous intestinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (1)

  • Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.

    PMID: 22192423DERIVED

MeSH Terms

Interventions

Pico-Salax

Study Officials

  • Lawrence Hookey, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Medicine

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

CA(1)