Therapeutic Study of ONO-4819CD for Ulcerative Colitis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2006

Last Updated Date

April 27, 2009

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Remission evaluated by DAI scores at 14 and 28 days

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00296556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Therapeutic Study of ONO-4819CD for Ulcerative Colitis

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: Rivenprost (drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2008

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00296556

Responsible Party

Hiroshi Nakase / Associate Professor, Kyoto University, Graduate School of Medicine

Study ID Numbers ^ICMJE

TRC05PG-II-1

Study Sponsor ^ICMJE

Kyoto University, Graduate School of Medicine

Collaborators ^ICMJE

National Institute of Biomedical Innovation

Investigators ^ICMJE

Study Chair:	Shuh Narumiya, MD, PhD	Kyoto University, Graduate School of Medicine
Principal Investigator:	Tsutomu Chiba, MD, PhD	Kyoto University, Graduate School of Medicine

Information Provided By

Kyoto University, Graduate School of Medicine

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP