E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post cholecystectomy bile acid diarrhoea/malabsorption |
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E.1.1.1 | Medical condition in easily understood language |
Diarrhoea or loose stools after surgical removal of the gall bladder, due to a disturbance of the normal bile acid regulation |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069703 |
E.1.2 | Term | Bile acid malabsorption |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008611 |
E.1.2 | Term | Cholecystectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066557 |
E.1.2 | Term | Chronic diarrhoea |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057229 |
E.1.2 | Term | Post cholecystectomy syndrome |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
|
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 |
Investigate changes in hormonal regulation (particularly by FGF19 and 7α-hydroxy-4-cholesten-3-one) and composition of the bile acid pool before and after elective cholecystectomy to deem the role of the intact gall bladder. |
|
E.2.2 | Secondary objectives of the trial |
Correlate changes in stool pattern correlated to the hormonal changes |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients between 18 and 80 yo. referred for elective cholcystectomy |
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E.4 | Principal exclusion criteria |
Prior bowel resection. Known chronic diarrhoeal disease (coeliac disease, lactose malabsorption, any inflammatory bowel disease), pregnancy or desire for pregnancy, contraindications to Xenbilox or constituents in the capsule, allergy to eggs. Chronic cholecystitis, recent (within 2 months) acute cholecystitis, known cirrosis, icterus. |
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E.5 End points |
E.5.1 | Primary end point(s) |
change in xenbilox stimulated FGF19 (delta 150min - 0 min) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Analysis of bloodsamples as soon as possible after LVLP, expected aprox. septemper 2017 |
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E.5.2 | Secondary end point(s) |
• change in plasma CDCA (chenodeoxycholic acid/xenbilox) absorption before vs after cholecystectomy (AUC) • change in fasting and stimulated C4 before vs after cholecystectomy • change in stool consistency before vs after cholecystectomy • change in stool pattern correlated to changes in FGF19 and C4 • Comparing of ΔFGF19 and fasting C4 between patients with normal stools and patients with diarrhoea. • change in blood lipid status after cholecystectomy • Change in abdominal symptoms and quality of life.
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
same as above for primary endpoint |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |