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

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.
 
ClinicalTrials.gov Identifier: NCT01929668
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: polyethylene glycol Drug: Ascorbic Acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
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
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who are willing to use the same preparation method for the next colonoscopy. [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Eun Soo Kim, MD, PhD Keimyung University School of Medicine
More Information
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Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT01929668    
Other Study ID Numbers: 2013-07-036-002
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Keywords provided by Eun Soo Kim, MD, PhD, Kyungpook National University Hospital:
ulcerative colitis
bowel preparation
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
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