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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643071
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Tacrolimus Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1 Drug: Tacrolimus
Oral
Other Name: FK506




Primary Outcome Measures :
  1. Improvement of Disease Activity Index score (DAI score) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes of DAI score ( Total & each item) [ Time Frame: 2 weeks ]
  2. Changes of clinical severity and symptom [ Time Frame: 12 weeks ]
  3. Endoscopic finding [ Time Frame: 12 weeks ]
  4. Patients impression [ Time Frame: 12 weeks ]
  5. Amount of steroid [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643071


Locations
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Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shin'etsu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00643071    
Other Study ID Numbers: F506-CL-1108
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Ulcerative colitis
Tacrolimus
FK506
Treatment outcome
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action