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

NCT00867438 | Completed Phase 2

• 1 other identifier: CB-01-05/04
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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™.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; Left-sided, mild to moderate ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• The number of patients achieving clinical remission (CAI <4).

  8 weeks

Secondary Outcomes (1)

• Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs.

  8 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Procedure: Sigmoidoscopy

2

EXPERIMENTAL

Procedure: Sigmoidoscopy

Interventions

Sigmoidoscopy PROCEDURE

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Sigmoidoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Antonio Gasbarrini, Prof

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 25, 2009

Record last verified: 2009-03