Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation

January 15, 2019 updated by: Dae Kyung Sohn, National Cancer Center, Korea

Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)

Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.

For bowel preparation, effective, well-tolerated and safe methods should be applied.

Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

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

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age, between 20 and 75
  2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy

Exclusion Criteria:

  • Gastrointestinal obstruction
  • Bowel perforation
  • Gastric retention
  • Ileus
  • Toxic colitis or toxic megacolon
  • Known allergies to components of the OSS and PEG-Asc
  • History of colorectal resection
  • History of abdominopelvic surgery within 6 months
  • uncontrolled electrolyte imbalance
  • hereditary Phenylketonuria
  • Severe dehydration status
  • seizure
  • coma
  • Glucose-6-phosphate dehydrogenase deficiency

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
Active Comparator: HAPREP® (PEG-Asc)

subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation

: PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]
Drug: HAPREP®

Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)

: : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]

Other Names:
  • 2L polyethylene glycol with ascorbic acidl PEG-Asc
Experimental: SUCLEAR® (OSS)

subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation

: OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
Drug: SUCLEAR®
Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
Other Names:
  • oral sulfate solution; OSS,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequacy of bowel preparation
Time Frame: on the day of colonoscopy
on the day of colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-point scale symptom questionnaire for drug tolerability
Time Frame: on the day of colonoscopy
4(distressing) or 5(severely distressing) point would be untolerable
on the day of colonoscopy
Number of Participants with Adverse Events
Time Frame: on the day of colonoscopy
on the day of colonoscopy
colonoscopy insertion time
Time Frame: on the day of colonoscopy
on the day of colonoscopy
adenoma detection rate
Time Frame: whithin 3 weeks from the day of colonoscopy
whithin 3 weeks from the day of colonoscopy

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Collaborators

Daehang Hospital

Investigators

  • Principal Investigator: Dae Kyung Sohn, M.D., National Cancer 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)

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCC2015-0210

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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