Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients (2SCANI)

April 27, 2016 updated by: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study

The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical 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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age >18 years old
  • ulcerative colitis patients without symptoms for at least 1 year
  • ulcerative colitis patients who undergo colonoscopy for surveillance

Exclusion Criteria:

  • subjects who had abdominal surgery
  • pregnant or breast feeding

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: polyethylene glycol
4L polyethylene glycol
Drug: polyethylene glycol
EXPERIMENTAL: polyethylene glycol with ascorbic acid
2L polyethylene glycol and ascorbic acid
Drug: Ascorbic Acid
Drug: polyethylene glycol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who are willing to use the same preparation method for the next colonoscopy.
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).
Time Frame: within 30 days after bowel preparation for colonoscopy
within 30 days after bowel preparation for colonoscopy

Collaborators and Investigators

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

Sponsor

Kyungpook National University Hospital

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

August 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (ESTIMATE)

August 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-07-036-002

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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