Status:
COMPLETED
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
Lead Sponsor:
Cosmo Technologies Ltd
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00867438
Start Date
January 1 2007
End Date
November 1 2007
Last Update
March 25 2009
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