Therapeutic Study of ONO-4819CD for Ulcerative Colitis

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyoto University, Graduate School of Medicine
• Collaborator: National Institute of Biomedical Innovation

Criteria

Inclusion Criteria:

1. Clinical diagnosis of ulcerative colitis

2. Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.

3. 20 years and above

4. Must obtain written informed consent

Exclusion Criteria:

1. Corticosteroids therapy within two weeks before enrollment

2. Immunosuppressive therapy within three months before enrollment

3. Leukocytapheresis therapy within one month before enrollment

4. Blood transfusion within two weeks before enrollment

5. Impaired renal function

6. Impaired hepatic function

7. Uncontrolled hypertension/hypotension

8. Uncontrolled arrhythmia

9. Impaired cardiac function

10. Cancer

11. Uncontrolled diabetes

12. Interstitial pneumonia

13. Glaucoma

14. History of colon resection

15. Infectious diseases needing medical treatments

16. Drug allergy

17. Pregnancy