A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy (CLEAR PREP)

Ferring

Status and phase

Completed

Phase 4

Conditions

Bowel Preparation

Treatments

Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)

Drug: mannitol

Drug: Bisacodyl

Study type

Interventional

Funder types

Industry

Identifiers

NCT02386449

000180

Details and patient eligibility

About

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.

Enrollment

184 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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