E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) without interuption of medication two weeks prior to test. |
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MedDRA Classification |
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 compare the sensitivity of the 13C-UBT test using the new test meal and the standard test meal for Hp in patients with dyspepsia taking PPI |
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E.2.2 | Secondary objectives of the trial |
To compare the specificity of the 13C-UBT using the new test meal and the standard test meal for Hp patients with dyspepsia taking PPI To compare the safety and tolerance of the new test meal with standard test meal To correlate the results of the Helicobacter Test INFAI using ne and standard test meal for Hp in patients with dyspepsia taking PPI: - Histoology score for Hp in antrum and corpus using the Uodate Sydney System - Sex - Age - BMI |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female patients of at least 18 years of age - All acid-related disorders requiring long-term PPI treatment including functional dyspepsia according Rome II Classification - Positive or negative standard 13C-UBT at screening - Diagnosis of Hp infection confirmed or excluded by combination of culture#, histology* and rapid** urease test on samples obtained bz endoscopy: - True positive: culture and/or (histology and rapid urease test) are positive - True negative: at least two tests are negative and culture is not positive - True negative: culture not evaluable and both histologz and urease test are negative. #) Culture will be based on antrum biopsies *) 4 endoscopic biopsies from antrum and 1 biopsy from corpus will be sampled. Histological processing and evaluation will beperformed for at least one sample of the antrum and the corpus. **) Rapid urease test will beperformed on the sampke of antrum biopsy. - Written informed consent of patient |
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E.4 | Principal exclusion criteria |
Previous Hp eradication therapy - intake of PPI, H2 receptors anatgonists, NSAIDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in 4 weeks prior to enrolment - Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated. - Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patients taking PPI, a positive test remains reliable for detection of Hp but the number of false negative tests risesdramatically reducing the sensitivity of these tests. Clinicians are frequently confronted with making a diagnosis of Hp infection in patients who may knowingly be taking PPI. Currently available breath and stool tests are reliable 12-14 days after discontinuation of PPI.
The aim of this study is to asses the sensitivity and specificity of the 13C UBT administered with the new test meal compared to standard Helicobacter Test INFAI in patients with dyspepsia taking PPI in a randomised blinded comparison. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
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 | |
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 months | 6 |