Therapeutic Study of ONO-4819CD for Ulcerative Colitis

Study Overview
=================
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 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.

Official Title
-----------------
A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Rivenprost (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rivenprost (drug)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission evaluated by DAI scores at 14 and 28 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis, EP4 agonist, PGE2