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

Phase 4

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®); Drug: mannitol; Drug: Bisacodyl

• Registration Number: NCT02386449
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Picoprep	sodium picosulfate, magnesium oxide and citric acid (Picoprep®)	sodium picosulfate, magnesium oxide and citric acid
Mannitol and Bisacodyl	mannitol	-
Mannitol and Bisacodyl	Bisacodyl	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects classified as success (Aronchick scale)	At visit 2 (day 1 of colonoscopy)	Defined as excellent or good according to the Aronchick scale

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects classified as success (Ottawa scale)	At visit 2 (day 1 of colonoscopy)	Defined as excellent, good or fair according to the Ottawa scale
Subject satisfaction (Likert scale)	At visit 2 (day 1 of colonoscopy)	As assessed by a subject survey using a 3 point Likert scale
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)	At visit 2 (day 1 of colonoscopy)	As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country); 🇧🇷 Sao Paulo, Brazil