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

A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02386449

Acronym

CLEAR PREP

Enrollment

184

Registered

2015-03-12

Start date

2015-02-28

Completion date

2015-12-31

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation

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.

Interventions

DRUGsodium picosulfate, magnesium oxide and citric acid (Picoprep®)

DRUGmannitol

DRUGBisacodyl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)	At visit 2 (day 1 of colonoscopy)	As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire
Subject satisfaction (Likert scale)	At visit 2 (day 1 of colonoscopy)	As assessed by a subject survey using a 3 point Likert scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026