E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastro-oesophageal reflux disease |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.0 |
E.1.2 | Level | llt |
E.1.2 | Classification code | 10038263 |
|
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 performance characteristics of ReQuest™ in Practice with doctors’ ordinary clinical judgement in the stepped down management of GORD |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
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 - GORD - Patients with symptoms the doctor believes to be due to GORD and which warrant in his view treatment with proton pump inhibitors
|
|
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 oesophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) - On initial endoscopy, presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett‘s oesophagus with 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, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; haematological 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 - Hypersensitivity to one of the compounds of the study medication - Alcohol, drug or medication abuse within the past year - Abnormal laboratory parameters and vital signs considered as clinically relevant by the investigator - Severe psychiatric or neurological 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, H2-receptor antagonists or prokinetics during the last 14 days before intake of study medication - Any medication for the purpose of the eradication of H. pylori during the last 28 days before intake of study medication - 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 intake of study medication; except regular intake of acetylsalicylic acid in dosages up to 150 mg/d
Concomitant medication: - PPIs, (except study medication), H2-receptor antagonists or prokinetics - 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 150 mg/d - Ketoconazole or other drugs with pH-dependent absorption - PPIs in combination with antibiotics for the purpose of the eradication of H. pylori - Initiation of daily psychotropic medication
Others: - Patients who are expected to be non-compliant and/or not cooperative - 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, relative 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary variable:
GORD symptom score of ReQuest™ in Practice after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved as assessed by the GORD symptom score of ReQuest™ in Practice after 16 weeks of treatment. The GORD symptom score of ReQuest™ in Practice will be calculated as the sum of the scores for acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea |
|
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) | 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 | 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) | Yes |
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.8.5 | 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
| |
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 | 10 |
E.8.9.1 | In the Member State concerned days | |