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

Ferring Pharmaceuticals184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

184

Conditions

Bowel Preparation

Interventions

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

mannitolDRUG

BisacodylDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country)

São Paulo, Brazil

Outcomes

Primary Outcomes

Percentage of subjects classified as success (Aronchick scale)

Defined as excellent or good according to the Aronchick scale

Time frame: At visit 2 (day 1 of colonoscopy)

Secondary Outcomes

Percentage of subjects classified as success (Ottawa scale)

Defined as excellent, good or fair according to the Ottawa scale

Time frame: At visit 2 (day 1 of colonoscopy)

Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)

As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire

Time frame: At visit 2 (day 1 of colonoscopy)

Subject satisfaction (Likert scale)

As assessed by a subject survey using a 3 point Likert scale

Time frame: At visit 2 (day 1 of colonoscopy)

Data from ClinicalTrials.gov

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