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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Keimyung University Dongsan Medical Center
Sponsor:
Information provided by (Responsible Party):
Kim Eun Soo, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier:
NCT01929668
First received: August 23, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Drug: polyethylene glycol
Drug: Ascorbic Acid

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

Resource links provided by NLM:


Further study details as provided by Keimyung University Dongsan Medical Center:

Primary Outcome Measures:
  • Number of patients who are willing to use the same preparation method for the next colonoscopy. [ Time Frame: day 1 ] [ Designated as safety issue: No ]

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). [ Time Frame: within 30 days after bowel preparation for colonoscopy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 114
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: polyethylene glycol
4L polyethylene glycol
Drug: polyethylene glycol
Experimental: polyethylene glycol with ascorbic acid
2L polyethylene glycol and ascorbic acid
Drug: polyethylene glycol Drug: Ascorbic Acid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929668

Contacts
Contact: Eun Soo Kim, MD. PhD +82-53-250-7088 dandy813@hanmail.net

Locations
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Principal Investigator: Eun Soo Kim, MD, PhD         
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
Principal Investigator: Eun Soo Kim, MD, PhD Keimyung University School of Medicine
  More Information

No publications provided

Responsible Party: Kim Eun Soo, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT01929668     History of Changes
Other Study ID Numbers: 2013-07-036-002
Study First Received: August 23, 2013
Last Updated: January 22, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Keimyung University Dongsan Medical Center:
ulcerative colitis
bowel preparation

Additional relevant MeSH terms:
Ascorbic Acid
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014