Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Ulcerative Colitis Clinical Trial

Official title:

Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643071
• Other study ID #: F506-CL-1108
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: August 25, 2014
• Start date: September 2006
• Est. completion date: May 2008

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

OR

• Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study

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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Tacrolimus
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)		12 weeks	No
Secondary	Changes of DAI score ( Total & each item)		2 weeks	No
Secondary	Changes of clinical severity and symptom		12 weeks	No
Secondary	Endoscopic finding		12 weeks	No
Secondary	Patients impression		12 weeks	No
Secondary	Amount of steroid		12 weeks	No

External Links

•   Link to Results on JAPIC - enter 140553 in the JapicCTI-RNo. field