Status:
TERMINATED
Therapeutic Study of ONO-4819CD for Ulcerative Colitis
Lead Sponsor:
Kyoto University, Graduate School of Medicine
Collaborating Sponsors:
National Institute of Biomedical Innovation
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
Detailed Description
Ulcerative colitis is a relapsing disease of unknown cause characterized by bloody diarrhea. Therapy usually involves 5-aminosalicylates, corticosteroids and immunosuppressants. However, steroid resis...
Eligibility Criteria
Inclusion
- Clinical diagnosis of ulcerative colitis
- Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.
- 20 years and above
- Must obtain written informed consent
Exclusion
- Corticosteroids therapy within two weeks before enrollment
- Immunosuppressive therapy within three months before enrollment
- Leukocytapheresis therapy within one month before enrollment
- Blood transfusion within two weeks before enrollment
- Impaired renal function
- Impaired hepatic function
- Uncontrolled hypertension/hypotension
- Uncontrolled arrhythmia
- Impaired cardiac function
- Cancer
- Uncontrolled diabetes
- Interstitial pneumonia
- Glaucoma
- History of colon resection
- Infectious diseases needing medical treatments
- Drug allergy
- Pregnancy
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00296556
Start Date
February 1 2006
End Date
March 1 2008
Last Update
April 28 2009
Active Locations (1)
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1
Kyoto University, Graduate School of Medicine
Kyoto, Japan, 606-8501