Clinical trial NCT00867438: Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
Official title: Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
Left-sided, mild to moderate ulcerative colitis
Lead sponsor: CosmoTech
Sponsor class: UNKNOWN
First posted: 2009-03-23
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 ≥ 4 and ≤ 10, and CAI ≥ 5 and ≤ 12.
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.
7. 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:

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.

Primary outcomes:
measure: The number of patients achieving clinical remission (CAI <4).
timeFrame: 8 weeks
Secondary outcomes:
measure: Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Internal Medicine
name: Antonio Gasbarrini, Prof
role: PRINCIPAL_INVESTIGATOR
References: