E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gastroesophageal reflux disease |
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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 | 10017885 |
E.1.2 | Term | Gastrooesophageal 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 |
The objective of the present study is the identification of factors (e.g. symptom patterns and symptom scores) determining the response to treatment with pantoprazole 40 mg o.d. as measured by different methods (e.g. ReQuest™ questionnaire, patient and investigator assessment). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent by the patient for study participation, prior to protocol specific procedures - Outpatients of at least 18 years of age (21 years in Argentina) - Patient considered by the investigator to have symptoms due to gastroesophageal reflux disease - Patients whose compliance is expected to be high with respect to the completion of the questionnaires and diaries (ReQuest™, GERDyzer™, HADS, TSS) according to the assessment of the investigator
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E.4 | Principal exclusion criteria |
Signs, indicating other gastrointestinal diseases: - Zollinger-Ellison syndrome or other gastric hypersecretory condition - Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) - On initial endoscopy, presence of obstructive esophageal strictures, Schatzki’s ring, esophageal diverticula, esophageal varices, achalasia or Barrett‘s esophagus with known high-grade dysplasia or longer than 3 cm - Acute peptic ulcer and/or ulcer complications - Inflammatory bowel diseases
Other concomitant diseases: - Severe or unstable cardiovascular (e.g., severe angina pectoris, postmyocardial infarction and ventricular extrasystoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant - Malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer - Tendency to react allergically to drugs, especially with known hypersensitivity to one of the compounds of the study medication - Alcohol, drug or medication abuse within the past year - Clinically relevant abnormal laboratory values and vital signs suggesting an underlying disease and requiring further clinical evaluation - Severe psychiatric or neurologic disorders
Special restrictions for female patients: - Pregnant or nursing female patients - Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized / hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Previous medication: - PPIs during the last 10 days before the start of the study - H2-receptor antagonists or prokinetics during the last 7 days before the start of the study - Any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before the start of the study; except regular intake of acetylsalicylic acid in dosages up to 163 mg/d
Concomitant medication: - PPIs (except study medication), H2-receptor antagonists, prokinetics, sucralfate, misoprostol, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) except regular intake of acetylsalicylic acid in dosages up to 163 mg/d - Ketoconazole or other drugs with pH-dependent absorption - PPIs in combination with antibiotics for the purpose of the eradication of H. pylori - Onset or change of psychotropic medication
Others: - Patients who are expected to be non-compliant and/or not co-operative - Participation in a clinical study within the last 30 days prior to the start of the study - Patients who have participated already in this study - Patients who are employees at the investigational site, relatives or spouse of the investigator - Any donation of germ cells, blood, organs, or bone marrow during the course of the study - Patients who are not contractually capable
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable of this study is the response to treatment with pantoprazole 40 mg o.d. at week 8 as measured by ReQuest™-GI in relation to various response factors as measured by ReQuest™ and its subscales |
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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 | No |
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 | No |
E.8.1.2 | Open | Yes |
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 | 10 |
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 | 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 | 3 |
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 | 3 |