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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01929668
First received: August 23, 2013
Last updated: April 27, 2016
Last verified: April 2016
  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 Kyungpook National University:

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 ]

Enrollment: 114
Study Start Date: August 2013
Study Completion Date: December 2014
Primary Completion Date: December 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   (Adult, Senior)
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

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

Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01929668     History of Changes
Other Study ID Numbers: 2013-07-036-002 
Study First Received: August 23, 2013
Last Updated: April 27, 2016
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
ulcerative colitis
bowel preparation

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

ClinicalTrials.gov processed this record on July 28, 2016