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Completed

NCT Number: NCT00347048

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

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.

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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

Chubu Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Tacrolimus

Drug

oral

Other names: FK506, Prograf

Placebo

Drug

oral

Primary outcomes

  1. Improvement of Disease activity index score (DAI score)

    Time frame: 2 Weeks

Secondary outcomes

  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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2006
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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