Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

August 22, 2019 updated by: Byung Chang KIM, National Cancer Center, Korea

Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)

The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

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

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study

Exclusion Criteria:

  • pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate < 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within < 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PMC/PEG-Asc
Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM
Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.

There is a difference in the order of intake between two group

Other Names:
  • Picosolution
  • Coolprep
ACTIVE_COMPARATOR: PEG-Asc/PMC
Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM
Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.

There is a difference in the order of intake between two group

Other Names:
  • Picosolution
  • Coolprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)
Time Frame: during colonoscopy
during colonoscopy

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Bun Kim, Dr, National Cancer Center, Korea

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

November 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2016-0166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Bowel Preparation

Clinical Trials on sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe