E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 study is to evaluate whether the patients are going to be relieved of the functional dyspepsia symptoms after being treated with Trimebutine 600 mg. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to evaluate, in the same target population, the difference between the percentages of subjects who had no longer symptoms of functional dyspepsia after being treated with Trimebutine 600 mg or placebo 600 mg. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A subject is eligible for inclusion in this study only if all of the following criteria apply: 1. Ambulant male and non pregnant female subjects. 2. Age between 18 and 75 years old (including the limits) at the randomisation visit. 3. History of epigastric pain or discomfort at least 1 of the last 7 days before randomisation. 4. Normal macroscopic findings from oesophagus, stomach and duodenum during the endoscopy which will take place 10 days (±4 days) prior to enrolment. 5.Willing and able to sign the informed consent prior to entry into the study.
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E.4 | Principal exclusion criteria |
Subjects will not be eligible for inclusion in this study if any of the following conditions apply: 1. Alarm symptoms (loss of weight, vomit, hematemesis, melaena, fever, icterus or any other sign which indicates serious or virulent disease). 2. Irritable Bowel Syndrome (IBS) as it was defined by Rome Criteria II (1999); abdominal pain for at least 12 weeks (not necessarily sequential) which has 2 or more of the below characteristics: Relieved with evacuation. Change at the frequency of the evacuations. Constitution of excrements. 3. Chronic serious constipation. 4. Patients with retrosternal burning pain. 5. History of serious or uncontrolled diseases. 6. History of peptic ulcer (endoscopy or radiogram) or gastroesophagical reflux disease (endoscopy), gastritis or other significant gastrointestinal disease. 7. History of peptic or other abdominal surgery (appendectomy and gynaecological surgeries excluded). 8. Patients with history of gallbladder surgery. 9. Pregnancy (examined with blood test) or breastfeeding. 10. Participation in a clinical trial within the previous month or current participation in any other clinical research study or clinical trial. 11. Abnormal physical, haematology and biochemistry examinations prior to enrolment (according to the investigator’s decision). 12. Use of non steroid antiflammatory drugs (during the study). 13. Usage of drugs that from the investigators point of view could cause dyspeptic symptoms. 14. Alcoholism or psychic disease which could lead to non compliance with the investigator’s instructions. 15. Known Hypersensitivity to drastic substance.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the relief of dyspeptic symptoms expressed for either treatment. This variable must be available for the patient to be included into this analysis. Any subject that lost follow –up will not be replaced. The analysis will test, separately in each sub-group, the reported relief from dyspeptic symptoms graded with GDSS. The test will be performed with the one-sample t-test vs. a constant. A secondary analysis will test whether the outcome measure is different in size between subgroups. This will be done by ANOVA, using as primary response variable the outcome measure, as explanatory factor the treatment, and as adjusting factor the country. If the country effect is not significant, no country adjustment will be applied to any subsequent analysis. If the treatment effect is not significant, all subsequent analyses shall be performed on the pooled measures (all assessable patients). This will have no inferential value and will only be descriptively used to estimate a possible treatment effect.
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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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |