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

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 ≥ 160 mm Hg; DAP ≥ 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.