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
1 other identifier
interventional
62
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2006
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedAugust 26, 2014
August 1, 2014
1.6 years
June 30, 2006
August 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of Disease activity index score (DAI score)
2 Weeks
Secondary Outcomes (5)
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
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kansai Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shin'etsu Region, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Study Start
September 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 26, 2014
Record last verified: 2014-08