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Sponsors and Collaborators: |
Kyoto University, Graduate School of Medicine National Institute of Biomedical Innovation |
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Information provided by: | Kyoto University, Graduate School of Medicine |
ClinicalTrials.gov Identifier: | NCT00296556 |
The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: Rivenprost (drug) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis. |
Estimated Enrollment: | 40 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shuh Narumiya, MD, PhD | +81-75-753-4392 | snaru@mfour.med.kyoto-u.ac.jp |
Contact: Toru Oga, MD, PhD | +81-75-753-4395 | t-oga@mfour.med.kyoto-u.ac.jp |
Japan | |
Kyoto University, Graduate School of Medicine | Recruiting |
Kyoto, Japan, 606-8501 | |
Contact: Toshiyuki Matsuoka, MD, PhD +81-75-753-4395 matsuoka@mfour.med.kyoto-u.ac.jp | |
Contact: Toru Oga, MD, PhD +81-75-753-4395 t-oga@mfour.med.kyoto-u.ac.jp | |
Sub-Investigator: Hiroshi Nakase, MD, PhD | |
Sub-Investigator: Minoru Matsuura, MD, PhD |
Study Chair: | Shuh Narumiya, MD, PhD | Kyoto University, Graduate School of Medicine |
Principal Investigator: | Tsutomu Chiba, MD, PhD | Kyoto University, Graduate School of Medicine |
Study ID Numbers: | TRC05PG-II-1 |
Study First Received: | February 24, 2006 |
Last Updated: | February 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00296556 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Ulcerative colitis, EP4 agonist, PGE2 |
Dinoprostone Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |