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

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929668
• Other study ID #: 2013-07-036-002
• Status: Completed
• Phase: N/A
• First received: August 23, 2013
• Last updated: April 27, 2016
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• polyethylene glycol

• Ascorbic Acid

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who are willing to use the same preparation method for the next colonoscopy.		day 1	No
Secondary	Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).		within 30 days after bowel preparation for colonoscopy	Yes