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Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
This study has been completed.
First Received: March 20, 2009   Last Updated: March 24, 2009   History of Changes
Sponsored by: Cosmo Technologies Ltd
Information provided by: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT00867438
  Purpose

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™.


Condition Intervention Phase
Ulcerative Colitis
Procedure: Sigmoidoscopy
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Cosmo Technologies Ltd:

Primary Outcome Measures:
  • The number of patients achieving clinical remission (CAI <4). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Procedure: Sigmoidoscopy
2: Experimental Procedure: Sigmoidoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867438

Sponsors and Collaborators
Cosmo Technologies Ltd
Investigators
Principal Investigator: Antonio Gasbarrini, Prof Department of Internal Medicine
  More Information

No publications provided

Responsible Party: Cosmo Technologies Ltd ( Cosmo Technologies Ltd )
Study ID Numbers: CB-01-05/04
Study First Received: March 20, 2009
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00867438     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cosmo Technologies Ltd:
ulcerative colitis
Left-sided, mild to moderate ulcerative colitis

Study placed in the following topic categories:
Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on August 25, 2009