Trial intelligence / Profile preview

High Dose Itopride for Bowel Preparation in Chronic Constipation

NCT01513811Phase 2

Key facts

Status: Completed
Start: Feb 2010
Primary completion: Nov 2011
Countries: 1
Sponsor: Shanghai Jiao Tong University School of Medicine
Modality: Small Molecules

Drugs: itopride
Conditions: constipation

Overview

Phase 2, randomised trial of itopride in constipation (3 arms), sponsored by Shanghai Jiao Tong University School of Medicine. Primary endpoint: Quality of bowel preparation. Started Feb 2010; status: completed.

Design

3 arms

Study design: Randomized

group PEG
PEG-E only.
group PEG+Itp
Itopride 150mg 30 min before PEG-E.
group PEG+4Itp
Itopride 150mg t.i.d 24h before + 150mg 30 min before PEG-E.

Who it enrols

Patients with chronic constipation (Rome III) suspected of colonic disease. Excludes patients with recent use of prokinetics or TCAs, bowel obstruction, or severe organ impairment.

Endpoints

Primary

Quality of bowel preparationDay of colonoscopy

Secondary

Intestinal bubble scaleDay of colonoscopy
Time of examinationDay of examination
Times of defecationDay of examination

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