E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active left-sided, mild to moderate ulcerative colitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the study is to evaluate the clinical efficacy and tolerability of the new Low Molecular Weight Heparin 210 mg formulation (CB-01-05-MMX) in patients with active moderate left-sided ulcerative colitis when administered at the daily dose for 8 weeks as an add on therapy to oral mesalazine, and compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are the evaluation of the endoscopic, histological and bio-humoral changes after 8 weeks of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female patients, between 18 and 70 years of age. 2. Patients with a conformed 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. (equal to or more than, less than) 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. 8. Ability to understand and willing to sign the Informed Consent Form, and other documents required to be read or signed by the subject.
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E.4 | Principal 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 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical Remission
A clinical remission is defined as Clinical Activity Index (CAI) reduction below 4. Clinical remission will be described as the total number and the percentage of patients in remission after 8 weeks of treatment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study is due to last until May 2007 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |