• Conditions: Medical Condition requiring a completed empty of the large bowel in preparation to a colonoscopy.; MedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002188-58-IT
• Lead Sponsor: PROMEFARM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

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

Inclusion Criteria

Patients aged between 18 and 85 yrs with chronic constipation undergoing a complete colonoscopy.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Hypersensitivity to any of the product ingredients. Pre-existing GI conditions: known or suspected gastrointestinal obstruction or perforation; severe colitis, megacolon, major colonic resection, significant gastroparesis, ileus. Pregnant or lactating women: women of childbearing potential will be required to have an urine pregnancy test.

Study & Design

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