Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Picosulfate sodium

Criteria

Inclusion Criteria:

• Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures

• Chinese citizen

• Males or females aged between 18 and 70 years inclusive

• Patients scheduled for colonoscopy

• Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure

Exclusion Criteria:

• Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control

• Taking concomitant lithium

• Allergy to any ingredient in the study medication

• History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)

• Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening

• Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)

• Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)

• Ascites

• History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)

• History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)

• Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation

• Severe liver damage

• Kidney function impairment

• Diabetics currently on insulin treatment

• Having participated in any other clinical trial during the 3 month prior recruitment

• Patients who are unable to act in a legal capacity, unable to meet or perform study requirements