Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium… (NCT00867438) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients achieving clinical remission (CAI <4).
. 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.