Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
1 other identifier
interventional
32
1 country
6
Brief Summary
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
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
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedAugust 26, 2014
August 1, 2014
1.7 years
March 20, 2008
August 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of Disease Activity Index score (DAI score)
12 weeks
Secondary Outcomes (5)
Changes of DAI score ( Total & each item)
2 weeks
Changes of clinical severity and symptom
12 weeks
Endoscopic finding
12 weeks
Patients impression
12 weeks
Amount of steroid
12 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Severe refractory UC patients who meets the following criteria
- Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding
- Steroid resistant or dependent
- Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study
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
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kanto, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Shin'etsu, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
September 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
August 26, 2014
Record last verified: 2014-08