Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00296556
Status:
TERMINATED
Last Update Posted:
2009-04-28
First Post:
2006-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Study of ONO-4819CD for Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2006-02-24', 'studyFirstSubmitQcDate': '2006-02-24', 'lastUpdatePostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission evaluated by DAI scores at 14 and 28 days'}], 'secondaryOutcomes': [{'measure': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ulcerative colitis', 'EP4 agonist', 'PGE2'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '11927615', 'type': 'BACKGROUND', 'citation': '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': '9124591', 'type': 'BACKGROUND', 'citation': 'Morimoto 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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.', 'detailedDescription': '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.\n\nProstaglandin 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.\n\nRecently, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of ulcerative colitis\n2. Mild to moderate ulcerative colitis refractory to 5-aminosalicylates therapy.\n3. 20 years and above\n4. Must obtain written informed consent\n\nExclusion Criteria:\n\n1. Corticosteroids therapy within two weeks before enrollment\n2. Immunosuppressive therapy within three months before enrollment\n3. Leukocytapheresis therapy within one month before enrollment\n4. Blood transfusion within two weeks before enrollment\n5. Impaired renal function\n6. Impaired hepatic function\n7. Uncontrolled hypertension/hypotension\n8. Uncontrolled arrhythmia\n9. Impaired cardiac function\n10. Cancer\n11. Uncontrolled diabetes\n12. Interstitial pneumonia\n13. Glaucoma\n14. History of colon resection\n15. Infectious diseases needing medical treatments\n16. Drug allergy\n17. Pregnancy'}, 'identificationModule': {'nctId': 'NCT00296556', 'briefTitle': 'Therapeutic Study of ONO-4819CD for Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University, Graduate School of Medicine'}, 'officialTitle': 'A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.', 'orgStudyIdInfo': {'id': 'TRC05PG-II-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivenprost (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8501', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University, Graduate School of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Shuh Narumiya, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyoto University, Graduate School of Medicine'}, {'name': 'Tsutomu Chiba, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyoto University, Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University, Graduate School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Biomedical Innovation', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Hiroshi Nakase / Associate Professor', 'oldOrganization': 'Kyoto University, Graduate School of Medicine'}}}}