Evaluation of a new reduced volume bowel preparation before colonoscopy Multicentre, randomised, observer-blind, parallel group,comparative study with a reference formulation - ND

• Conditions: Bowel cleansing prior to colonoscopy; MedDRA version: 9.1Level: HLTClassification code 10017963Term: Gastrointestinal and abdominal imaging procedures

• Registration Number: EUCTR2008-007144-33-IT
• Lead Sponsor: PROMEFARM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In-patients and out-patients of both sexes aged between 18 and 85 yr undergoing a complete colonoscopy for various reasons.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

serious gastrointestinal disease; serious cardiovascular disease, severe liver failure; end-stage renal insufficiency; pregnant or at risk of becoming pregnant, lactating women; hypersensitivity to the active principles or other ingredients; history of anaphylaxis or allergic reactions in general;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified