E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sleep-related breathing disorders
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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 objective of this proof-of-concept study is to assess the potential benefit of pantoprazole for patients with and without evidence of GERD and sleep-related breathing disorders |
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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 - Male and female outpatients of at least 18 years of age - Patients suffering from sleep-related breathing disorders / Upper airway resistance syndrome for at least 3 months prior to start of the study who are seeking help for their snoring - Stratum I: Patients with evidence of GERD, Stratum II: Patients without evidence of GERD
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E.4 | Principal exclusion criteria |
Signs indicating gastrointestinal diseases and/or other causes of sleep disturbances as specified: - Primary insomnia (according to DSM-IV) - Patients under nCPAP/BiPAP during the last week - 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) - Known 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
Other concomitant diseases: - Acute respiratory tract infection - 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 - 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 and H2-receptor antagonists during the last 2 weeks before intake of study medication - Any medication for the purpose of the eradication of H. pylori during the last 3 months before intake of study medication
Concomitant medication - PPIs (except study medication), H2-receptor antagonists - Ketoconazole or other drugs with pH-dependent absorption - PPIs in combination with antibiotics for the purpose of the eradication of H. pylori - Onset of daily psychotropic medication - Regular intake or onset of hypnotics, e.g. benzodiazepines, chloralhydrate and combinations, barbiturates (exception: mild phytotherapeutics (e.g. valerian, hop and combinations))
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, 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) |
Variable of primary interest:
The primary variable of this study is the comparison of the ratio of snoring time over sleeping time (Snoring Index)
Secondary variables: - Change in ventilation (oral / nasal flow) including: - Peakflow Vmax - Tidal volume (Vt)
- Change in Apnea-Hypopnea index - Comparison of the ratio of respiratory cycles with and without snoring - Changes in Polysomnography: - EEG - EOG - EMG - ECG - Blood Gas Analysis
- Proportion of REM phases - Proportion of NREM stage 3 and 4 - Arousal Index (according to ASDA criteria) - Calgary Sleep Apnea Quality of Life Index - Stanford Sleepiness Scale (SSS) - Epworth Sleepiness Scale (ESS) - ReQuest - Vital signs and physical examination
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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.8.3 |
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.8.6 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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |