A Phase 2 interventional study of Rivenprost (drug) in Ulcerative Colitis, sponsored by Kyoto University, Graduate School of Medicine. Terminated at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2009-04-28.
Sponsored by Kyoto University, Graduate School of Medicine · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
Ulcerative colitis is a relapsing disease of unknown cause characterized by bloody diarrhea. Therapy usually involves 5-aminosalicylates, corticosteroids and immunosuppressants. However, steroid resistance and dependency can become problematic. Immunosuppressive drugs, such as azathioprine, are beneficial but may have serious side effects. Therefore, new therapeutic approach is needed.
Prostaglandin E2 is one of the prostanoids, which is involved with innate immunity. PGE2 induces oral tolerance to specific antigen in the small intestine and downregulates the production and release of proinflammatory cytokines by macrophages and neutrophils. Accordingly, PGE2 is considered to be the mediator of mucosal protection.
Recently, it was elucidated that disruption of EP4 gene, which is one of PGE receptors, caused severe colitis in mice. Moreover, EP4-selective agonist (AE1-734) was also revealed to ameliorate severe dextran sodium sulfate-induced colitis in mice. We therefore examined the effects of 2 weeks intravenous EP4-selective agonist therapy for patients with mild to moderate ulcerative colitis.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 7 is below the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Kyoto University, Graduate School of Medicine is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Remission evaluated by DAI scores at 14 and 28 days
Improvement by DAI scores; Change in DAI scores; CAI scores at 3, 7, 14 and 28 days; Colonoscopic and histopathological scores at 14 and 28 days; Clinical severity and symptom scores at 7, 14 and 28 days; Cytokines at 7, 14 and 28 days; Adverse effects.
This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Kyoto University, Graduate School of Medicine