E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Gastro oesophageal reflux disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 work is to identify the percentage of patients/participants for whom the dosage of proton pump inhibitor (PPI) can be lowered without affecting the efficacy of the treatment. Efficacy will be evaluated based on return of symtoms of gastro- esophageal reflux disease.
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this work is to identify the percentage of patients/participants for whom the dosage of proton pump inhibitor (PPI) can be lowered without affecting the efficacy of the treatment. Efficacy will be evaluated based on changes in scores on an evaluation scale (Glasgow-Dyspepsia scale). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
We plan to recruit 100 patients with endoscopy verified erosive esophagitis, 18 years and older, equally many males and females. These have recently been identified by review of endoscopy reports between 2005 and 2010. Patients on daily PPIs for more than 2 years of PPI therapy will be recruited. |
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E.4 | Principal exclusion criteria |
Exclusion criteria are: symptomatic GERD, age> 80 years, lactose intolerance, severe co-morbidities such as malignancy or severe heart or lung disease, alcoholism, H. pylori infection and inability to understand Icelandic.
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E.5 End points |
E.5.1 | Primary end point(s) |
Willingness to continue on the research dosage at the end of two months, defined as no significant experience of dyspeptic symptoms |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the study period |
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E.5.2 | Secondary end point(s) |
Significant changes in Glasgow Dispepsia Score and the amount of Rennie-tablets taken at the end of two months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the study period |
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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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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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At the end of the study period patients will be able to go back to their previous dosage. Those who where randomised to a half a dose and reached primary end point will be able to lower their dosage. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |