Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy

Inclusion criteria

• Male and female patients, between 18 and 70 years of age.
• 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 .
• 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).
• Patients with mild to moderate active ulcerative colitis, as defined by the DAI ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤ 12.
• Women with negative serum test for pregnancy.
• 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.
• Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.

Exclusion criteria

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