E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gastroesophageal reflux disease (GERD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066874 |
E.1.2 | Term | Gastroesophageal reflux 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 |
1. To establish the efficacy of the treatment with 40 mg of pantoprazole in patients with reflux esophagitis and in those with non-erosive reflux disease (NERD) 2. To establish the effect of the treatment duration on the healing of reflux esophagitis and non-erosive reflux disease (NERD)
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E.2.2 | Secondary objectives of the trial |
1. To establish the effect of the treatment with pantoprazole 40 mg on the quality of life of patients with reflux esophagitis and in patients with non-erosive reflux disease (NERD) 2. To define the factors influencing acute therapy 3. To quantify the rate of adverse events associated with pantoprazole treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
– Patients of both genders at the age over 18 – Patients with typical GERD symptoms (heartburn/or regurgitation) – Signed informed consent
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E.4 | Principal exclusion criteria |
– Patients with esophageal or gastric malignancies – Patients with a terminal condition – Patients with renal impairment (serum creatinine > 300 µmol/l) – Pregnancy and breast-feeding – Patients positive for Helicobacter pylori infection – Patients with GERD symptoms who have been unsuccessfully treated with proton pump inhibitors during a period of 6 months prior to inclusion – Patients with Barretts’ esophagus – Patients with evidence of dysplasia – Patients with active ulcer disease (gastric, duodenal) – Patients who have been treated with a proton pump inhibitor 30 days or less prior to the first visit – Hypersensitivity to pantoprazole – Patients taking any medicine that should influence the results of the treatment – Patients not able out of any reason to make decisions about participation in the study or not able to fulfill the requirements of the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
1. To establish the efficacy of the treatment with 40 mg of pantoprazole in patients with reflux esophagitis and in those with non-erosive reflux disease (NERD) 2. To establish the effect of the treatment duration on the healing of reflux esophagitis and non-erosive reflux disease (NERD)
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
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last visit of last patient |
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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 | 0 |
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 | 0 |
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 |