Is Picoprep and Moviprep equally adequate, safe and tolerable in the adequate bowel cleansing for colonosocpy?

• Conditions: Patients who need a colonoscopy for screening, surveillance or diagnosis of a disease have to be prepared by bowel cleansing; MedDRA version: 14.1Level: LLTClassification code 10010009Term: Colonoscopy and sigmoidoscopy abnormalSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: LLTClassification code 10010010Term: Colonoscopy and sigmoidoscopy normalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-004384-75-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-10
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient 18 years and older, who have to uindergo a colonoscopy and who are able to give their informed consent and are eligible to undergo bowel-cleansing
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patients with significant gastroparesis or gastric outlet obstruction; ileus; known or suspected bowel obstruction or perforation; severe chronic renal failure (creatinine clearance < 30mL/minute); severe congestive heart failure (AHA class III or IV); toxic colitis or megacolon. Also, patients with a subtotal colectomy or a colostomy will be excluded because of insufficient remaining colonic surface to evaluate the effects of bowel cleansing.

Study & Design

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