E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
diarrhoea of travellers to South- and Southeast-Asia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021907 |
E.1.2 | Term | Infectious diarrhea |
|
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 |
efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea |
|
E.2.2 | Secondary objectives of the trial |
toxicity of rifaximin, prevention of post infectious irritable bowel syndrome |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adults ≥ 18 und < 65 years - Good general condition (according to history) - Written informed consent - No pregnancy - No breast feeding - Efficacious contraception (hormonal conctraception, intrauterine device, condoms or diaphragm with spermicide) during the study and 4 weeks after termination of the study - No participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study - Travel period between 6 and 28 days - Travel to South- and Southeast Asia - Time to arrival in the country ≤ 24 hours
|
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E.4 | Principal exclusion criteria |
- Pregnancy - Breast feeding - Age < 18 and ≥ 65 years - No written informed consent - Chronic gastrointestinal disease and / or immunoinsufficiency - Low general condition (according to history) - Regular medication with gastrointestinal side-effects and / or immunosuppressive / or lactosis - Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study - No efficacious contraception - Travel period < 6 and > 28 days - Travel outside South- and Southeast Asia - Vaccination against cholera using DUKORAL within 12 months prior to inclusion - Time to arrival in the country > 24 hours - nown hypersensitvity against rifaximin or rifamycine-derivatives in general
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of the prevention of traveller´s diarhoea (by measurement of frequency and consistence of the stool as well as other gastrointestial complaints) with rifaximin Toxicity of rifaximin |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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
| |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |