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

Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00347048

Enrollment

Registered

2006-07-04

Start date

2006-09-30

Completion date

2008-04-30

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis, tacrolimus, FK506, treatment outcome

Brief summary

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.

Interventions

DRUGtacrolimus

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Improvement of Disease activity index score (DAI score)	2 Weeks

Secondary

Measure	Time frame
Changes of DAI score ( Total & each item)	2 Weeks
Changes of clinical severity and symptom	2 Weeks
Endoscopic finding	2 Weeks
Patients impression	2 Weeks
Amount of steroid	2 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026