E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
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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 |
To evaluate the clinical response of rCTB given in a dose of 5 mg three times a week for two weeks to treat active Crohn`s disease (CD). |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety and tolerability of rCTB given in a dose of 5 mg three times a week for two weeks. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Male or female aged 18 to 70 years. • A previously established diagnosis of Crohn´s disease verified with enteroclysis/small bowel follow-through, barium enema, endoscopy or histology. Should be performed within 24 months prior to study initiation. • Active disease of mild to moderate degree. CDAI (Crohn´s Disease Activity Index) score ≥ 220 and ≤ 400. • If ongoing treatment with sulphasalazine (SASP) or 5-ASA, corticostereoids or immunomodulators, the dose regimen must have been unchanged for at least 4 weeks and must have been initiated at least 12 weeks prior to inclusion. • CRP>5. • Give written informed consent to participate. • Willing and able to communicate with the Investigator and understand the requirements of the study. • Females should unless being menopausal agree to use reliable contraception (hormonal contraceptives or intra-uterine device), at least from 1 month prior to inclusion until three months after last intake of study drug.
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E.4 | Principal exclusion criteria |
• Treatment with metronidazole within the last four weeks. • Treatment with any biological drug, including infliximab, within 12 weeks. • Has received Dukoral in the last year. • Patient with a known intestinal stricture or symptoms or history indicating a stenotic condition. • Active fistulating disease. • Any condition which would limit the patient’s ability to complete the study in the opinion of the Investigator. • History of drug or chemical abuse in the year before the study. • Receipt of any other investigational product in the month before study entry. • Concomitant participation in any other clinical study. • Donation of blood 6 weeks before study entry or at any time during the study. • Females who are pregnant or lactating.
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of patients with a reduction in CDAI score of 100 points or more between pre-dose and 2 weeks after last dose (at day 29). |
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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 | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last visit of the last subject |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |