E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with typical symptoms of functional dyspepsia (intermittent pain or burning localized to the epigastrum of at least moderate severity at least once per week with a total duration of at least 6 months) according to ROME III criteria and three items of GIS judged at least as moderate including reflux symptoms at Visit 1 or 3. |
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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 show the superiority of STW 5 compared to placebo for the treatment of patients with functional dyspepsia with concomitant reflux symptoms |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of STW 5 and to assess the effect of STW 5 on the esophageal pH-profile and reflux characteristic. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of either sex aged 18-80 years. 2. Diagnosis of functional dyspepsia according to Rome III criteria:
3. At assessment (Visit 1 or 2) three items of GIS have to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture 4. Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could explain the symptoms (findings of up to 5 gastric erosions can be tolerated if patient has no concomitant intake of acetylsalicylic acid) 5. Patients willing to comply with the study protocol. 6. Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).
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E.4 | Principal exclusion criteria |
1. Concomitant treatment during the study with any medication that could influence the gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant, laxatives, calcium antagonists, beta-blocker, antidiarrhetics) 2. Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily) 3. History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer 4. History of gastric and/or duodenal ulcer 5. History of abdominal surgery (cholecystectomy and appendectomy can be tolerated) 6. Food allergies and known lactose intolerance 7. Evidence of any gastrointestinal infectious diseases 8. Participation in a clinical trial 30 days prior to this trial 9. Concurrent participation in another clinical trial 10. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception. 11. History and/or presence of drug or alcohol abuse 12. Patients with psychiatric illness 13. No irritable bowel
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E.5 End points |
E.5.1 | Primary end point(s) |
AUC of patients` assessment of gastrointestinal symptoms evaluated by daily VAS scale |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 9 |
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
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last visit of the last subject |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |