Therapeutic Study of ONO-4819CD for Ulcerative Colitis

This study has been terminated.
(terminated)
Sponsor:
Collaborator:
National Institute of Biomedical Innovation
Information provided by:
Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00296556
First received: February 24, 2006
Last updated: April 27, 2009
Last verified: April 2009

February 24, 2006
April 27, 2009
February 2006
December 2007   (final data collection date for primary outcome measure)
Remission evaluated by DAI scores at 14 and 28 days
Same as current
Complete list of historical versions of study NCT00296556 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Therapeutic Study of ONO-4819CD for Ulcerative Colitis
A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Rivenprost (drug)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
March 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00296556
TRC05PG-II-1
Yes
Hiroshi Nakase / Associate Professor, Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
National Institute of Biomedical Innovation
Study Chair: Shuh Narumiya, MD, PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Tsutomu Chiba, MD, PhD Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
April 2009

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