E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastritis associated with H. pylori infection |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the stomach lining caused by infection with H. pylori bacteria. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051790 |
E.1.2 | Term | Helicobacter pylori gastritis |
E.1.2 | System Organ Class | 100000004862 |
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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 find out if netazepide can heal inflammation of the stomach lining caused by H. pylori infection.
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E.2.2 | Secondary objectives of the trial |
To find out if netazepide: has any effect on 'biomarkers' - substances related to stomach health stomach health and function (gastrin, chromogranin A and pepsinogens I & II); can get rid of H. pylori infection; can get rid of symptoms of indigestion; and has any important side effects in people with H. pylori infection. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women aged 30-75 years 2. Positive H. pylori blood test and breath test 3. Otherwise good general health as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests 4. Body mass index 18-32 kg/m^2 5. Able to give fully-informed, written consent 6. Able to communicate with study personnel 7. Reliable, willing, and likely to comply with the protocol 8. Consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS) |
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E.4 | Principal exclusion criteria |
We exclude the participants who meet the following criteria:
* not in good general health (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine); abuse of alcohol or drugs; drink, on average, more than 21 units of alcohol weekly (14 units for women); taken certain medicines or herbal remedies (ones that may affect the way the body handles or responds to the study medicine) up to 12 weeks before screening; have had a serious reaction to any medicine - particularly benzodiazepines; have had any condition or operation that might affect the way the body absorbs medicines; have had previous treatment for an H. pylori infection; objection by GP on medical grounds because they might increase the risk; or confound the assessment of netazepide; mental illness might compromise consent;
* pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol - because of the potential risk to the unborn or breastfed baby;
* have donated blood, or taken part in another study, within the past 3 months; or don't agree not to donate blood, or take part in another study, during the 3 months after this study - because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood; or
* smokers of more than 5 cigarettes a day - because participants must be able to comfortably abstain from smoking during the study
Those criteria are designed to select healthy participants, who are robust enough to recover quickly from any adverse effects of netazepide.
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E.5 End points |
E.5.1 | Primary end point(s) |
* Visual assessment of gastric mucosa at gastroscopy * Histology and real-time PCR of gastric biopsies for biomarkers (such as chromogranin A (CgA), histidine decarboxylase (HDC), matrix metalloproteinase-7 (MMP-7) and interferon gamma) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Gastroscopy with biopsies: at baseline (Visit 3, before 1st dose) and after 12 weeks' treatment (Visit 7) with the study medicine |
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E.5.2 | Secondary end point(s) |
1. 13C urease breath test and Giemsa staining of gastric biopsies for the presence of H. pylori infection
2. Serum gastrin and pepsinogens I & II, and plasma CgA concentrations
3. Trough and peak pharmacokinetic (PK) parameters of netazepide
4. Symptoms of dyspepsia (indigestion)
5. Safety and tolerability of netazepide as judged by medical examination; ECG; vital signs; safety tests of blood and urine; and adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Breath test: at screening (Visit 2) and after 12 weeks' treatment (Visit 7)
Biopsies: taken at gastroscopy before and after 12 weeks' treatment
2. Samples for gastrin, pepsinogens 1 and 2, and CgA, at baseline, after 3, 6, 9 and 12 weeks' treatment, and at follow-up.
3. Samples for PK of netazepide: predose and 1 hour post-dose (tmax) after the first dose, and after 6 and 12 weeks' treatment.
4. Dyspepsia questionnaire before and after 12 weeks' treatment.
5. Medical examination, ECG and vital signs: at baseline and after 3, 6, 9 and 12 weeks' treatment.
Safety blood and urine tests: at baseline and after 3, 6, 9 and 12 weeks' treatment.
Adverse events: monitored continually throughout the study. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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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In accordance with the Human Tissue Act, no biopsy sample can be stored or analysed after the study has been declared over. Therefore, the end of the trial is defined as the last visit of the last subject, or completion of the last bioanalysis, whichever is later. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |