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Completed

NCT Number: NCT00643071

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chūbu, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Oral

Other names: FK506

Primary outcomes

  1. Improvement of Disease Activity Index score (DAI score)

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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