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NCT02579733 Clinical Trial

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

Ulcerative Colitis Clinical Trial

— ACE  

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02579733
Other study ID # KMU-151016
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 1, 2016
Est. completion date December 1, 2018

Study information
Verified date August 2019
Source Kyungpook National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azathioprine

• Placebo

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (2)
Lead Sponsor Collaborator
Kyungpook National University Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mucosal healing status Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score. one year
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