E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
The primary objective of this study is to develop, and test, an algorithm for a priori identification of responders to empirical esomeprazole treatment in general practice.
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E.2.2 | Secondary objectives of the trial |
To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)). To compare time to response between esomeprazole and placebo. Time to response is defined as the first day of sustained absence of the key complaint. To describe the key complaints. To assess patient satisfaction. To asses disease impact on quality of life and certain health economic parameters.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Attend general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent. 2.Provision of written informed consent. 3.Age ≥ 18 years.
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E.4 | Principal exclusion criteria |
1.Symptoms indicating Irritable Bowel Syndrome (IBS) as judged by the investigator. 2.Any "alarm symptoms" such as significant unintended weight loss, vomiting, dysphagia, hematemesis, melena, fever, jaundice or any other signs indicating serious or malignant disease. 3.Treatment with medication for all acid related symptoms and / or peptic ulcer disease. Any such treatment must be stopped before the patient enters the study. 4.Treatment with proton pump inhibitors within 2 weeks prior to visit 1. 5.Treatment with medication that could interact with esomeprazole, e.g. diazepam, phenytoin and warfarin. 6.Past or present disease likely to interfere with the evaluation of the study results. 7.Known or suspected allergy to esomeprazole. 8.Women, who are pregnant, breast feeding, or planning a pregnancy during the study. 9.Women of childbearing potential, unless they maintain adequate contraception (intrauterine device, surgical sterilisation or hormonal contraception). 10.Alcohol- or drug abuse or any conditions (e.g. mental illness or dementia) associated with poor compliance. 11.Treatment with any non-approved compound within the month prior to start of study medication. 12.Previous inclusion in this study at any time or participation in other clinical trials within the last month. 13.Need for an interpreter.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy The primary efficacy variable is the patient’s key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.
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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 | Yes |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |