Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: June 30, 2006
Last updated: August 25, 2014
Last verified: August 2014
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 3

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

Resource links provided by NLM:

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
Experimental: 1 Drug: tacrolimus
Other Names:
  • FK506
  • Prograf
Placebo Comparator: 2 Drug: Placebo


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

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00347048

Chubu region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shin'etsu region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00347048     History of Changes
Other Study ID Numbers: F506-CL-1107 
Study First Received: June 30, 2006
Last Updated: August 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Ulcerative colitis
treatment outcome

Additional relevant MeSH terms:
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016