Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND

COSMO TECHNOLOGIES LTD0 个研究点目标入组 120 人开始时间: 2006年12月20日最近更新: 2012年3月19日

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•1. Male and female patients, between 18 and 70 years of age. 2. Patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-ASA derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study. 3. Presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum up to 15 cm proximal to the anus . 4. Patients with mild to moderate active ulcerative colitis, as defined by the DAI 61619; 4 and 61603; 10, and CAI 8805; 5 and 8804; 12. 5. Women with negative serum test for pregnancy. 6. Women of childbearing potential should not start a pregnancy during the course of the trial and for the following four weeks, since dangerous effects for the foetus can not be excluded. In case of pregnancy occurrence they must inform immediately the investigator responsible for the trial. 7. Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Presence of other clinically significant medical condition as determined by the Investigator. 2. History of hypersensitivity or idiosyncratic reaction to heparins. 3. History of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction. 4. Presence of arterial hypertension SAP 61619; 160 mm Hg; DAP 61619; 95 mm Hg . 5. Receipt of any investigational agent within 90 days of starting treatment. 6. Use of rectal 5-ASAs or rectal corticosteroids within 2 weeks before the starting the study. 7. Use of anti-TNF agents or immunosuppressive drugs such as azothioprine, 6-mercaptopurine or cyclosporine A in the last 3 months. 8. Patients with ulcerative colitis of severe entity DAI 10 or CAI 12 , or with limited distal ulcerative proctitis, or with infectious colitis confirmed by microbiological assessment in stool. 9. Patients with severe intestinal bleeding, or with Hb 9 g/dL. 10. Presence of significant hepatic impairment AST, ALT 2 ULN . 11. Presence of significant renal impairment creatinine 2 ULN . 12. Women who are pregnant or who are breast feeding. 13. Intestinal obstruction. 14. Presence of type 1 or type 2 diabetes. 15. Concomitant oral antibiotic treatment, within 2 weeks before starting the study.

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