E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Short Bowel Syndrome with intestinal failure (SBS IF) |
Korttarmssyndrom med intestinal svigt |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022683 |
E.1.2 | Term | Intestinal malabsorption |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036430 |
E.1.2 | Term | Post surgical malabsorption NOS |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042822 |
E.1.2 | Term | Syndrome malabsorption |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the trial is to assessthe therapeutic effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®) for SBS patients with an end-jejunostomi. The efficacy is assessed through the ability of liraglutide (Victoza®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia, and determine if liraglutide (Victoza®) can reduce the need for parenteral support. |
Projektet har til formål at undersøge effekten af glucagon-like peptide-1 (GLP-1) analogen, liraglutide (Victoza®), på patienter med korttarmssyndrom og jejunostomi. Der fokuseres på liraglutides (Victoza®) evne til at øge intestinal absorption, reducere patientens diarré og behov for hyperfagi samt at afgøre, om liraglutide (Victoza®) kan reducere behovet for parenteral væsketerapi. |
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E.2.2 | Secondary objectives of the trial |
To test possible biomarkers for determination of intestinal adaptation. p-citrulline, p-paracetamol absorptions test, |
. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with intestinal failure and short bowel syndrome and a jejunostomy
Age 18 to 90 years |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Faecal weight/stoma output |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before and at the end of 8 weeks of treatment with Victoza |
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E.5.2 | Secondary end point(s) |
Change in:
urinary volume
oral intake
parenteral volume support
Fluid composite effect
Body weight
Body composition (DEXA)
Mesenteric blood flow |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before and at the end of 8 weeks of treatment with Victoza |
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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 | Yes |
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 | 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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |