E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a healthy volunteer trial designed to investigate if long-term treatment with nexium is the cause of a clinically significant acid rebound phenomenon. The intended indication for nexium is treatment of gastrooesophageal reflux disease, gastric and duodenal ulcers. |
|
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 investigate the clinical relevance of the acid rebound phenomenon by comparing the occurence of refluxsymptoms in the actively treated group versus the placebogroup. |
|
E.2.2 | Secondary objectives of the trial |
Analysis of the significance of helicobacter pylori infection. Comparison of the consumption of escape medication. Comparison of symptom scores in GSRS in week 9, 10, 11 and 12 in the active treated group versus the placebo group. Time to first reflux symptom defined as score > 1 in one of the questions or a to-tal score > 2 in the reflux part of GSRS. The impact of symptoms related to the acid rebound phenomena on QOL. The correlation between symptoms and s-gastrin and s-chromogranin A. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
|
E.4 | Principal exclusion criteria |
Dyspepsia within the preceeding 4 weeks Heartburn or acid regurgitation within the last 4 weeks Previous treatment with PPI or H2-blockers Previous contact to a doctor or hospital because of dyspepsia or reflux Previous abdominal surgery Use of NSAID, antacids, antidepressives and other analgesics on a regulary basis Potential language problems in understanding information and registering symp-toms Pregnancy or breast feeding Other diseases which can affect the symptom registration
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the symptom scores in the reflux part of the GSRS in weeks 9,10,11 and 12 in the actively treated group versus the placebo group. |
|
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
One arm with cross over from active treatment to placebo at week 8 |
|
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |