Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-04-30

Brief Summary

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This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

oral

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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tacrolimus

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe refractory UC patients
* Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
* Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction

Exclusion Criteria

* Mild or fulminant type
* Renal failure patients, hepatic failure patients
* Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
* Patients who received LCAP or GCAP within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
* Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.

Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No