E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional dyspepsia (FD) |
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E.1.1.1 | Medical condition in easily understood language |
A disorder characterised by pain and discomfort in the upper digestive tract. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 assess the effect of UDC on duodenal permeability and meal related sensory motor function in patients with functional dyspepsia |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of UDC on bile acid (BA) concentration/composition, BA receptor expression, duodenal low-grade inflammation, nutrient tolerance and dyspeptic symptom occurence |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Patient has functional dyspepsia, defined by the Rome III criteria. The patient must have at least one cardinal symptom for the last 3 months, with symptom onset at least 6 months prior to screening and in the absence of organic, metabolic or systemic diseases that can explain these symptoms. b. Patient has to discontinue intake of proton pump inhibitors, NSAIDs and drugs effecting gastric motility for 14 weeks. They have to replace oral anticonception with non-oral anticonception. c. Women need to use non-oral anticonception |
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E.4 | Principal exclusion criteria |
a. Patient is under the age of legal consent. b. Female patients who are pregnant or breastfeeding. c. Patient is allergic to bile acids d. Patient has active stomach or gut ulcer, liver or bowel disorders e. Patient has biliary colic, calcified gallstones, not well functioning gall bladder, obstruction of gallbladder and acute inflammation of gallbladder f. Patient is gluten intolerant, lactose intolerant, diabetes mellitus, Crohn's disease, ulcerative colitis, allergy (asthma, eczema, allergic to bile acids), problems with coagulation. g. Patient with first degree family members with gluten intolerance, Crohn's disease or diabetes mellitus. h. Severe kidney malfunction i.Intake of Intake of oral anticonception, barbiturates, antacid, colestyramine or colestipol, nitrendipine , cyclosporine, ciprofloxacine, rosuvastatine and PPIs, NSAIDs and drugs effecting gastric motility. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duodenal permeability and meal related sensory motor function |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Trial lasts for 12 weeks: all end points are measured during week 4 and week 12.
|
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E.5.2 | Secondary end point(s) |
duodenal luminal bile salt conposition/concentration duodenal low-grade inflammation nutrient tolerance dyspeptic symptom onset BA receptor expression |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Trial lasts for 12 weeks: all end points are measured during week 4 and week 12. |
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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 | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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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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 | |
E.8.9.1 | In the Member State concerned days | |