CompletedPhase 2

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

133 participantsStarted 2007-01

Plain-language 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™.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

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

Timeframe: 8 weeks

Trial details

NCT IDNCT00867438

SponsorCosmo Technologies Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

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