Study Stopped
terminated
Therapeutic Study of ONO-4819CD for Ulcerative Colitis
A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 28, 2009
April 1, 2009
1.8 years
February 24, 2006
April 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission evaluated by DAI scores at 14 and 28 days
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of ulcerative colitis
- Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.
- years and above
- Must obtain written informed consent
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyoto University, Graduate School of Medicine
Kyoto, 606-8501, Japan
Related Publications (2)
Kabashima K, Saji T, Murata T, Nagamachi M, Matsuoka T, Segi E, Tsuboi K, Sugimoto Y, Kobayashi T, Miyachi Y, Ichikawa A, Narumiya S. The prostaglandin receptor EP4 suppresses colitis, mucosal damage and CD4 cell activation in the gut. J Clin Invest. 2002 Apr;109(7):883-93. doi: 10.1172/JCI14459.
PMID: 11927615BACKGROUNDMorimoto K, Sugimoto Y, Katsuyama M, Oida H, Tsuboi K, Kishi K, Kinoshita Y, Negishi M, Chiba T, Narumiya S, Ichikawa A. Cellular localization of mRNAs for prostaglandin E receptor subtypes in mouse gastrointestinal tract. Am J Physiol. 1997 Mar;272(3 Pt 1):G681-7. doi: 10.1152/ajpgi.1997.272.3.G681.
PMID: 9124591BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 27, 2006
Study Start
February 1, 2006
Primary Completion
December 1, 2007
Study Completion
March 1, 2008
Last Updated
April 28, 2009
Record last verified: 2009-04