Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00347048

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: tacrolimus Drug: Placebo	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Improvement of Disease activity index score (DAI score) [ Time Frame: 2 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: 2 Weeks ] [ Designated as safety issue: No ]
Endoscopic finding [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Patients impression [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Amount of steroid [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Enrollment:	62
Study Start Date:	September 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tacrolimus oral
2: Placebo Comparator	Drug: Placebo oral

Eligibility

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

Criteria

Inclusion Criteria:

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

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: NCT00347048

Locations

Japan

Hokkaido region, Japan

Shin'etsu region, Japan

Kanto region, Japan

Kyushu region, Japan

Kansai region, Japan

Chubu region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	F506-CL-1107
Study First Received:	June 30, 2006
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00347048
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Ulcerative colitis
tacrolimus
FK506
treatment outcome

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Tacrolimus
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009