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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Tacrolimus

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Tacrolimus, FK506, Treatment outcome

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Improvement of Disease Activity Index score (DAI score)

Secondary Outcome Measures

Changes of DAI score ( Total & each item)

Changes of clinical severity and symptom

Endoscopic finding

Patients impression

Amount of steroid

Full Information

NCT ID

NCT00643071

First Posted

March 20, 2008

Last Updated

August 25, 2014

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00643071

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative colitis, Tacrolimus, FK506, Treatment outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Other Intervention Name(s)

FK506

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Improvement of Disease Activity Index score (DAI score)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Changes of DAI score ( Total & each item)

Time Frame

2 weeks

Title

Changes of clinical severity and symptom

Time Frame

12 weeks

Title

Endoscopic finding

Time Frame

12 weeks

Title

Patients impression

Time Frame

12 weeks

Title

Amount of steroid

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chubu

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyusyu

Country

Japan

City

Shin'etsu

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

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

Learn more about this trial

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

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