Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: tacrolimus (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
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.
Clinical Details
Official title: Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement of Disease activity index score (DAI score)
Secondary outcome: Changes of DAI score ( Total & each item)Changes of clinical severity and symptom Endoscopic finding Patients impression Amount of steroid
Eligibility
Minimum age: 16 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Hokkaido region, Japan
Shin'etsu region, Japan
Kanto region, Japan
Chubu region, Japan
Kansai region, Japan
Kyushu region, Japan
Additional Information
Starting date: September 2006
Ending date: April 2008
Last updated: May 19, 2008
|
