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NCT00347048 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00347048
Other study ID # F506-CL-1107
Secondary ID
Status Completed
Phase Phase 3
First received June 30, 2006
Last updated August 25, 2014
Start date September 2006
Est. completion date April 2008

Study information
Verified date August 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 64 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus
oral
• Placebo
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of Disease activity index score (DAI score) 2 Weeks No
Secondary Changes of DAI score ( Total & each item) 2 Weeks No
Secondary Changes of clinical severity and symptom 2 Weeks No
Secondary Endoscopic finding 2 Weeks No
Secondary Patients impression 2 Weeks No
Secondary Amount of steroid 2 Weeks No
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