search
Back to results

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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
polyethylene glycol
Ascorbic Acid
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ulcerative Colitis focused on measuring ulcerative colitis, bowel preparation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Dongsan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

polyethylene glycol

polyethylene glycol with ascorbic acid

Arm Description

4L polyethylene glycol

2L polyethylene glycol and ascorbic acid

Outcomes

Primary Outcome Measures

Number of patients who are willing to use the same preparation method for the next colonoscopy.

Secondary Outcome Measures

Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).

Full Information

First Posted
August 23, 2013
Last Updated
April 27, 2016
Sponsor
Kyungpook National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01929668
Brief Title
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients
Acronym
2SCANI
Official Title
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, bowel preparation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyethylene glycol
Arm Type
Active Comparator
Arm Description
4L polyethylene glycol
Arm Title
polyethylene glycol with ascorbic acid
Arm Type
Experimental
Arm Description
2L polyethylene glycol and ascorbic acid
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Primary Outcome Measure Information:
Title
Number of patients who are willing to use the same preparation method for the next colonoscopy.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Soo Kim, MD, PhD
Organizational Affiliation
Keimyung University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs