Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis (ACE)
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|ClinicalTrials.gov Identifier: NCT02579733|
Recruitment Status : Terminated (Not enough number of enrolling patient)
First Posted : October 20, 2015
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Azathioprine Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Active Comparator: Azathioprine
Azathioprine (1.5mg/kg) po for 1 year
Placebo Comparator: Sugar pill
Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year
- Mucosal healing status [ Time Frame: one year ]Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.
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): NCT02579733
|Korea, Republic of|
|Kyungpook National University Hospital|
|Daegu, Korea, Republic of, 41944|
|Principal Investigator:||Eun Soo Kim, MD, PhD||Kyungpook National University|