E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017885 |
E.1.2 | Term | Gastrooesophageal reflux disease |
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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 repeated oral dose of V0337 SO 01A (10 ml, 4 times per day) administered during 7 days in comparison to placebo in patients suffering from symptoms of gastro-oesophageal reflux disease (GORD) |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of repeated oral dose of V0337 SO 01A (10 ml, 4 times per day) administered during 7 days in patients suffering from symptoms of gastro-oesophageal reflux disease (GORD) in term of adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Will be included patients who fulfil the following criteria: - out patients of both gender aged from 18 to 60 years, - suffering from GORD-related symptoms including heartburn, and/or epigastric pain and regurgitation, *for at least two weeks before the inclusion visit, *and at least 2 days during the week preceding the inclusion visit, *with a heartburn at least grade 3 on a 6-point Lickert scale at the inclusion visit, - able to give a written informed consent, - able to understand the protocol, to accept the constraints of the study and to come to the visits, - patient who, in the judgement of the investigator is likely to be compliant during the study, - registered with a social security or health insurance system, - in case of women of childbearing potential, she has to present a negative urinary pregnancy test at inclusion visit and currently to use an efficient contraceptive method for at least 2 menstrual cycles and at least 1 month after the study end (hormonal contraceptive formulations, IUD, tubal ligation status). |
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E.4 | Principal exclusion criteria |
- GORD symptoms needing a treatment by PPI, - worsening general status, - history of gastro duodenal or oesophageal surgery or vagotomy, - history of or severe oesophagitis (grade C or D of Los Angeles classification), - history of Zollinger-Ellison syndrome, - any cardio-vascular, renal, hepatic, gastro-intestinal, endocrine, haematological, neuro-psychiatric severe diseases that will not be compatible with the participation to the study in the opinion of the investigator, - history of alcohol or drug abuse, - renal chronic dialysis, - any diet without salt, - any allergy or history of allergy to one compound of the tested drugs.
Criteria related to treatments: -treatment by H2 blocker or PPI within the 15 days preceding the inclusion visit, -treatment by antacid (including OTC drugs) or alginates within the 15 days preceding the inclusion visit, -treatment by metoclopramide or domperidone within the 3 days preceding the inclusion, -chronic treatment by NSAID within the 15 days preceding the inclusion visit, -treatment by furosemide, or tetracyclines, or digoxine, or isoniazide, or anticholinergic drugs within the month preceding the inclusion visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of heartburn intensity assessed by the patient between D1 (visit 1) and D8 (visit 2) on a 6-point Lickert scale (none, very mild, mild, moderate, severe, very severe). |
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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 | 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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 28 |
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 | 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
| |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |