A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Bisacodyl; Citric Acid; Magnesium Oxide; Mannitol; Picosulfate sodium; Sodium Citrate

Criteria

Inclusion Criteria:

• Men or women aged 18 to 60 years

• Subjects scheduled for an elective colonoscopy

• Women of child-bearing potential using at least one highly effective contraceptive method

• Subjects able to understand all instructions

• Informed consent signed

Exclusion Criteria:

• Hypersensitivity to active ingredients

• Female participants pregnant or with a positive blood pregnancy test

• Acute surgical abdomen

• Previous colorectal surgery

• Gastrointestinal (GI) surgery

• GI diseases, active inflammatory bowel disease, colon disease

• Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease

• Use of laxatives or antidiarrheal agents 72 hours prior to screening

• Significant alterations in laboratory values or other diseases that could interfere with the results