Trials / Terminated
TerminatedNCT02579733
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Kyungpook National University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azathioprine | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2015-10-20
- Last updated
- 2019-08-14
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02579733. Inclusion in this directory is not an endorsement.