E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional heartburn and reflux hypersensitivity with incomplete respons to proton pomp inhibitors |
Reflux hypersensitiviteit of functioneel zuurbranden met onvoldoende respons op proton pomp inhibitoren |
|
E.1.1.1 | Medical condition in easily understood language |
Functional heartburn and reflux hypersensitivity |
Functioneel zuurbranden en reflux hypersensitiviteit |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 |
To assess the efficacy of Citalopram on reflux parameters, reflux symptoms and esophageal sensitivity for 8 weeks treatment in patients with reflux hypersensitivity or functional heartburn with incomplete response to PPI therapy |
De doeltreffendheid van Citalopram op reflux parameters, reflux symptomen en de gevoeligheid van de slokdarm nagaan in patienten met functioneel zuurbranden of reflux hypersensitiviteit met onvoldoende respons op zuurremmende medicatie na 8 weken behandeling met citalopram |
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E.2.2 | Secondary objectives of the trial |
To assess the predictive value of reflux assessment, the assessment of esophageal sensitivity and questionnaire results on the primary outcome |
De voorspellende waarde van de beoordeling van reflux, de beoordeling van de gevoeligheid van de slokdarm en de resultaten van de vragenlijsten op het primaire eindpunt na te gaan. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age: between 18 and 75 years old
- Proven reflux on a 24 hour pH-impedance montoring or esophagitis > grade A
- History of GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
-Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy |
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E.4 | Principal exclusion criteria |
- Endoscopic signs of severe erosive esophagitis (≥ grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- Systemic diseases, known to affect esophageal motility.
- Surgery in the thorax or in the upper part of the abdomen.
- Treatment with citalopram prior to the start of the study.
- Major psychiatric disorder.
- Regular use of medications such as: anticholinergics, tricycle antidepressants.
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. - Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
- Pregnancy or breast feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change in symptom severity assesed by reflux questionnaires
- Change in reflux parameters assessed by 24 hour impedance-pH
- Change in esophageal sensitivity assessed by a multimodal esophageal stimulation procedure
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 8 weeks of citalopram intake |
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E.5.2 | Secondary end point(s) |
- Predictive value of reflux assessment
- Predictive value of assessment of esophageal sensitivity
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 8 weeks of citalopram intake |
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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) | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |