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

• Conditions: Patients with mild to moderate active ulcerative colitis; MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative

• Registration Number: EUCTR2006-001782-42-IT
• Lead Sponsor: COSMO TECHNOLOGIES LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the study is to evaluate the clinical efficacy and tolerability of the new Low Molecular Weight Heparin 210 mg formulation CB-01-05-MMXTM in patients with active moderate left-sided ulcerative colitis, when administered at the daily dose for 8 weeks, and compared to placebo.;Secondary Objective: Secondary objectives of the trial are the evaluation of the endoscopic, histological and bio-humoral changes after 8 weeks of treatment.;Primary end point(s): The number of patients achieving clinical remission CAI 4 after 8 weeks of treatment with CB-01-05-MMXTM or with placebo.The number of patients achieving endoscopic healing at the end of treatment.