Tacrolimus (FK506) P-III, Open-Label Study in Refractory Ulcerative Colitis Patients - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00643071

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Tacrolimus	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Improvement of Disease Activity Index score (DAI score) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes of DAI score ( Total & each item) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Changes of clinical severity and symptom [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Endoscopic finding [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patients impression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Amount of steroid [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	September 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Tacrolimus Oral

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.

Eligibility

Ages Eligible for Study:	16 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643071

Locations

Japan

Hokkaido, Japan

Shin'etsu, Japan

Kanto, Japan

Chubu, Japan

Kansai, Japan

Kyusyu, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma, Inc. ( Director )
Study ID Numbers:	F506-CL-1108
Study First Received:	March 20, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00643071 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Ulcerative colitis
Tacrolimus
FK506
Treatment outcome

Study placed in the following topic categories:

Digestive System Diseases
Immunologic Factors
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Tacrolimus
Intestinal Diseases
Gastroenteritis
Immunosuppressive Agents
Colitis

Additional relevant MeSH terms:

Immunologic Factors
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Tacrolimus

Intestinal Diseases
Immunosuppressive Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on May 07, 2009