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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02579733 |
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Date of registration:
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16/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
ACE |
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Scientific title:
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Date of first enrolment:
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February 1, 2016 |
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Target sample size:
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16 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02579733 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Eun Soo Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyungpook National University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Placebo
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Drug: Azathioprine
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Primary Outcome(s)
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Mucosal healing status
[Time Frame: one year]
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Secondary ID(s)
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KMU-151016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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