E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient having a high digestive obstruction of malignant origin i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) for whom surgery is inappropriate. |
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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 |
The primary objective of this study is to assess the efficacy of lanreotide 30 mg as compared to placebo to relieve clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of lanreotide 30 mg as compared to placebo in terms of: - vomiting improvement or decrease in the secretion volume sucked up by a nasogastric tube, - nausea improvement, - pain improvement, - well-being improvement, - symptom improvement delay, - symptom improvement duration, - concomitant medications consumption, - hospitalisation duration. To assess the clinical and biological safety of treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient having given a written informed consent before completing any study-related procedure, • Patient being over 18 years of age, • Patient having a high digestive obstruction i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) , • Patient having a digestive obstruction of malignant origin1, • Patient having peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months1, • Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube1, • Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours1, • Patient being treated by intra-venous corticoids since at least 5 days and intra-venous proton pump inhibitors, • Patient having an estimated survival of more than one month, • Patient accepting to comply fully with the protocol.
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E.4 | Principal exclusion criteria |
Patient having an operable obstruction1, • Patient having a colic obstruction1 (must be documented by an abdominal X-Ray within the previous 3 days), • Patient having received any specific anticancer therapy within the previous 15 days, • Patient receiving any antiH2 receptor blockers1, • Patient having a bowel obstruction which could be explained by a non malignant cause (hypokaliaemia, drug side-effects, renal insufficiency,..), • Patient having signs of bowel perforation, • Patient having received somatostatin or any analogue as treatment of the bowel obstruction, • Patient having a contra-indication to intra-muscular injections,
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of responder patients at D7. A responder patient will be defined either as a patient experiencing one or less vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days. Number or vomiting episode or volume of daily drainage will be therefore recorded on each day from D0 (V1) to D7 (V3).
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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 | Information not present in EudraCT |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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End of study is last patient last visit
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |