Therapeutic Study of ONO-4819CD for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Rivenprost (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No