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Tacrolimus (FK506) Study in Moderate to Severe 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: NCT00347048
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Drug: tacrolimus Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf
Placebo Comparator: 2 Drug: Placebo
oral



Primary Outcome Measures :
  1. Improvement of Disease activity index score (DAI score) [ Time Frame: 2 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: 2 Weeks ]
  3. Endoscopic finding [ Time Frame: 2 Weeks ]
  4. Patients impression [ Time Frame: 2 Weeks ]
  5. Amount of steroid [ Time Frame: 2 Weeks ]


Information from the National Library of Medicine

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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:

  • 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.

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): NCT00347048


Locations
Japan
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
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00347048     History of Changes
Other Study ID Numbers: F506-CL-1107
First Posted: July 4, 2006    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:
Colitis
Ulcer
Colitis, Ulcerative
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