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

January 11, 2016 updated by: Ferring Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Picoprep
sodium picosulfate, magnesium oxide and citric acid
Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
Active Comparator: Mannitol and Bisacodyl
Drug: Bisacodyl
Drug: mannitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects classified as success (Aronchick scale)
Time Frame: At visit 2 (day 1 of colonoscopy)
Defined as excellent or good according to the Aronchick scale
At visit 2 (day 1 of colonoscopy)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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