Azathioprine Based on Endoscopy After Clinical Remission... | NCT02579733

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

NCT02579733

Sponsor

Kyungpook National University Hospital

Status

Terminated

Last Update Posted

Aug 14, 2019Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Ulcerative Colitis

Interventions

Azathioprine
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough number of enrolling patient

Expanded Access Info

Start Date

Feb 1, 2016

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Oct 16, 2015

First Submission Date that Met QC Criteria

Oct 16, 2015

First Posted Date

Oct 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2019

Last Update Posted Date

Aug 14, 2019Actual

Name	Class
Celltrion	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azathioprine	Active Comparator	Azathioprine (1.5mg/kg) po for 1 year	Drug: Azathioprine
Sugar pill	Placebo Comparator	Placebo drug identical to azathioprine (1.5mg/kg) po for 1 year	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azathioprine	Drug		Azathioprine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mucosal healing status	Mucosal healing status will be assessed by sigmoidoscopy using Mayo endoscopic score.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eun Soo Kim, MD, PhD	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Daegu		41944	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40013523	Derived	Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D013872	Thionucleosides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D015122	Mercaptopurine