A prospective, randomised study comparing a 3-sachet Picolax® treatment with the standard 2-sachet Picolax® for bowel cleansing prior to colonoscopy. - Picolax® 2- .v. 3-Sachet
- Conditions
- Bowel preparation prior to elective complete colonoscopy. As 'bowel preparation' is not a specific medical condition, there is no MedDRA term.
- Registration Number
- EUCTR2007-003735-23-GB
- Lead Sponsor
- Ferring Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
- Written informed consent
- Patient referred for elective complete colonoscopy
- = 18 years of age
- Willing, able and competent to complete the entire procedure and to comply with study instructions
- Females of childbearing potential must undergo a pregnancy test
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
- Pregnancy
- Hypersensitivity to any of the ingredients of the product
- Congestive cardiac failure
- Gastric retention
- Active gastro-intestinal ulceration
- Toxic colitis
- Toxic megacolon
- Ileus
- Nausea and vomiting
- Acute surgical abdominal conditions such as acute appendicitis
- Known or suspected gastro-intestinal obstruction or perforation
- Patients with severely reduced renal function
- Participation in another clinical study in the last 30 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method