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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929668
First Posted: August 28, 2013
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Eun Soo Kim, MD, PhD, 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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 23, 2013
First Posted: August 28, 2013
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Eun Soo Kim, MD, PhD, 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