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Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

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Disease Information

Descriptive Information
Brief Title † Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
Official Title †
Brief Summary The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.
Detailed Description The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required. The placebo drug which is identical to azathioprine will be provided by Celltrion drug company. Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used.
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary Outcome Measure † Mucosal healing status
Secondary Outcome Measure †
Condition † Ulcerative Colitis
Intervention † DrugAzathioprine
Study Arms / Comparison Groups Azathioprine Azathioprine (1.5mg/kg) po for 1 year Sugar pill Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 52
Start Date † February 2016
Completion Date February 2018
Primary Completion Date December 2017
Eligibility Criteria † Inclusion Criteria: - Ulcerative colitis patients with moderate to severe activity who achieved a clinical remission by the first course of corticosteroids - Newly diagnosed or without steroid use during last 1 year - Endoscopic Mayo subscore >0 Exclusion Criteria: - Patients with azathioprine or biologics therapy
Gender Both
Ages 18 Years - 80 Years
Accepts Healthy Volunteers No
Contacts †† Eun Soo Kim, MD, PhD, dandy813@hanmail.net
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT02579733
Organization ID KMU-151016
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Kyungpook National University
Collaborators †† Celltrion
Investigators † Principal Investigator: Eun Soo Kim, MD, PhD, Kyungpook National University
Information Provided By
Verification Date December 2016
First Received Date † October 16, 2015
Last Updated Date December 26, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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