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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Changes of DAI score ( Total & each item) [ Time Frame: 2 Weeks ]
  • Changes of clinical severity and symptom [ Time Frame: 2 Weeks ]
  • Endoscopic finding [ Time Frame: 2 Weeks ]
  • Patients impression [ Time Frame: 2 Weeks ]
  • Amount of steroid [ Time Frame: 2 Weeks ]

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   (Child, Adult)
Sexes Eligible for Study:   All
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 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 Identifier: NCT00347048     History of Changes
Other Study ID Numbers: F506-CL-1107
Study First Received: June 30, 2006
Last Updated: August 25, 2014

Keywords provided by Astellas Pharma Inc:
Ulcerative colitis
treatment outcome

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017