E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of moderate, active Crohn’s disease: induction of remission. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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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 |
Dose range finding study to evaluate the efficacy (induction of remission) and safety of 3 doses of Rifaximin-EIR 400 mg tablet versus placebo in the treatment of active, moderate Crohn’s disease. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• patients of either sex; • patients aged between 18 and 75 years old, inclusively; • diagnosis of Crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously; • patients with a CDAI of ≥ 220 to ≤ 400; • patients capable of and willing to conform to the study protocol; • patients who have provided signed and dated written informed consent.
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E.4 | Principal exclusion criteria |
• patients potentially needing immediate surgery for Crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above; • patients with active perianal Crohn’s disease; • patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement; • patients with symptoms attributed to Short Bowel Syndrome or previous surgery; • patients with stoma; • patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum Crohn’s disease) alone or in combination with colitis or ileitis; • patients treated with: - oral steroids and budesonide less than 30 days prior to screening; - i.v. steroids less than 30 days prior to screening; - antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening; - rectal steroids less than 30 days prior to the screening visit; - anti-tumour necrosis factor (anti-TNF) and other biological therapies less than 6 months prior to the screening visit; • pregnant women or nursing mothers; • females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment; • patients with severe hepatic insufficiency (Child C); • patients with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 – 4); • patients with known hypersensitivity to Rifaximin; • any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological or neoplastic disease; • withdrawal of informed consent; • patients who have used any investigational drug (except biological therapies) within 3 months prior to screening; • patients who have donated 250 ml or more of blood in the last 3 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical remission (defined as reduction in CDAI score < 150 points) at 12 weeks.
Secondary end points: • clinical response defined as a reduction in CDAI of ≥ 100 points from baseline value; • clinical response defined as a reduction in CDAI of ≥ 70 points from baseline value; • time to obtain clinical response and remission; • maintenance of clinical remission at second week after stopping therapy; • maintenance of clinical remission, i.e. CDAI score < 150 points at the end of follow-up; (12 weeks after stopping therapy); • number of treatment failures; • definition of therapeutic dose to be used in subsequent phase III clinical trials.
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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 | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |