NCT00380497

Brief Summary

The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

September 25, 2006

Last Update Submit

July 25, 2013

Conditions

Colonoscopy

Keywords

PediatricsColonoscopyBowel cleanoutPoly-Ethylene GlycolPico-Salax

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents

Secondary Outcomes (2)

  • Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached

  • Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)

Study Arms (2)

Pico-Salax

EXPERIMENTAL
Drug: Pico-Salax®

PEGlyte

ACTIVE COMPARATOR
Drug: PEG-Lyte®

Interventions

PEG-Lyte®DRUG
PEGlyte
Pico-Salax®DRUG
Pico-Salax

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 4 and 18 years of age
  • Undergoing full elective ambulatory colonoscopy

You may not qualify if:

  • Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR\<50 mls/min/1.73 m2)
  • Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate \>90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Pico-Salax

Study Officials

  • Simon Ling, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Gastroenterologist

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations

CA(1)