Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

February 20, 2019 updated by: Eun Ran Kim, Samsung Medical Center

Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study

Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

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

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 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion Criteria:

  • History of gastrointestinal tract surgery
  • History of inflammatory bowel disease
  • History of severe active colitis
  • History of chronic kidney disease
  • pregnant woman.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2L PEG-Asc
2L PEG-Asc for bowel preparation
Drug: 2L PEG-Asc
PEG-Asc powder
Other Names:
  • clicool
  • coolprep
Active Comparator: 1L PEG-Asc & 'Bisacodyl 10Mg Suppository
1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation
Drug: Bisacodyl 10Mg Suppository
bisacodyl 10 mg suppository
Drug: 1L PEG-Asc
PEG-Asc powder
Other Names:
  • clicool
  • coolprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Bowel Preparation Scale (BBPS).
Time Frame: 1 hour
4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)
1 hour

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: brian.biochem@gmail.com Kim, Samsung Medical Center

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 (Actual)

July 31, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-05-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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