E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All adult patients with a small bowel fistula with an output > 500ml/day or a an enterostomy with an output > 1500ml/day after gastro-intestinal, abdominal wall surgery. Randomization is possible if patients are at least 4 weeks postoperative and had at least 2 weeks of standard care (loperamide, codeine, PPI). |
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E.1.1.1 | Medical condition in easily understood language |
a highoutput pathway between intestine and the skin, either created by a surgeon or spontaneous after complicated surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 |
To assess the impact of treatment with Lanreotide versus current standard of treatment on output reduction in patients with high output enterocutaneous fistulas or enterostomies. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are days to full oral or enteral nutrition, change in need of intravenous fluid/TPN per week, time to reach the maximal effect in fistula or enterostomy output, percent reduction in total fistula or enterostomy output from pre randomisation, total number of days in hospital, changes in needed electrolytes (calcium, magnesium, potassium, phosphate, bicarbonate), wound care, quality of life (EQ-5D/qaly’s), analysis of costs, absolute fistula or enterostomy output volume at endpoint compared with output volume at randomisation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients with high output enterocutaneous fistula (>500ml/day) or high output enterostomy (>1500ml/day) existing for at 4 weeks after surgery where the clinical decision has been made by the treating team to reduce output using medical therapy (standard regimen, i.e. PPI, codeine, loperamide, reduction in oral intake) for at least 2 weeks. |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Recent treatment with short-acting somatostatin (or analogues) for a consecutive period of more than 1 week (within past 3 months)
• Patients with high output pancreatic fistula after pancreatitis
• Patients with symptomatic gallbladder disease
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of responders in week 8. Definition of a responder is a decrease in output of >25% at week 8 compared with baseline output at randomisation (Output will be assessed for 8 weeks or until surgery if within 8 weeks; in mL/24 hrs;) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
the primairy outcome will be measured 8 weeks after randomisation |
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E.5.2 | Secondary end point(s) |
• days to full oral or enteral nutrition
• change in amount of TPN/week
• time to reach the maximal effect in fistula output.
• Percent reduction in total output from pre randomisation
• no. of days in hospital
• changes in needed iv fluid
• changes in needed electrolytes
• Wound care
• Quality of life
• Analysis of costs
• Absolute output volume at endpoint compared with output volume at randomisation.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
8 weeks and 16 weeks after randomisation |
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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 | 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 | Yes |
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) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard treatment of care |
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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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |