Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), 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.

Active, not recruiting

• Conditions: Active left-sided, mild to moderate ulcerative colitis; MedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2006-001782-42-HU
• Lead Sponsor: Cosmo Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Male and female patients, between 18 and 70 years of age.
2.Patients with a conformed 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 =4 and = 10, and CAI = 5 and =12. (equal to or more than, equal to or less than)
5.Women with negative serum test for pregnancy.
6.Women of childbearing potential provided they use adequate contraceptive precautions during the treatment period. Adequate contraceptive methods are defined as those with a failure rate <1% per year when correctly used, and include implants, injectables, combined oral pills, some IUDs or a vasectomised partner in a stable relationship.
8.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
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: The 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-MMX) in patients with active moderate left-sided ulcerative colitis when administered at the daily dose for 8 weeks as an add on therapy to oral mesalazine, and compared to placebo.;Secondary Objective: The 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): Clinical Remission<br><br>A clinical remission is defined as Clinical Activity Index (CAI) reduction below 4.<br>Clinical remission will be described as the total number and the percentage of patients in remission after 8 weeks of treatment.<br><br>