Trial intelligence / Profile preview

Low-volume vs Standard PEG for Colonoscopy

NCT01929590Phase 3

Key facts

Status: Completed
Start: Oct 2011
Primary completion: Jun 2012
Countries: 1
Sponsor: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Modality: Injectable Hydrogels, Implantable Hydrogels, Biodegradable Polymers

Drugs: polyethylene glycol 3350
Conditions: bowel preparation

Overview

Phase 3, randomised, open-label trial of polyethylene glycol 3350 in bowel preparation (3 arms), sponsored by Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Primary endpoint: Satisfactory Bowel Preparation (Boston Bowel Preparation Scale). Started Oct 2011; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Single Dose 4L
PEG-3350 4L taken the day before the procedure
Split Dose 2L+2L
PEG-3350 2L taken the day before and 2L taken the morning of the procedure
Low Volume 2L
PEG-3350 2L taken the morning of the procedure

Who it enrols

In-hospital patients with an indication for colonoscopy, excluding those under 18, with severe illness (cardiac, renal, metabolic), major psychiatric illness, or known allergies to PEG-3350.

Endpoints

Primary

Satisfactory Bowel Preparation (Boston Bowel Preparation Scale)at colonoscopy

Secondary

Tolerability (Nausea, Vomiting, Abdominal Pain)before colonoscopy
Compliance with Bowel Preparationbefore colonoscopy
Sleep Disturbancebefore colonoscopy
Adverse Effectsbefore colonoscopy

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