E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inoperable malignant bowel obstruction |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006055 |
E.1.2 | Term | Bowel obstruction |
|
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 efficacy of lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of lanreotide 120 mg in terms of: - Number of daily vomiting episodes recorded on diary cards or measurement of the daily drainage by nasoogastric tube (NGT), - Number of days without vomiting episodes, - Number of daily nausea episodes recorded on diary cards, - Intensity of abdominal pain assessed on a visual analogue scale, - Well-being assessed on a visual analogue scale, - Time between first injection (inclusion) and clinical response, To assess the clinical and biological safety of the treatment
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient MUST satisfy ALL of the following inclusion criteria before he/she will be allowed to participate in the study: • Patient have to give written (personally signed and dated) informed consent before completing any study-related procedure. Demographic criteria • ≥18 years of age. Criteria related to the disease • diagnosis of a digestive obstruction of malignant origin, confirmed by a CT scan within the previous 3 months, • inoperability as decided after surgical consultation |
|
E.4 | Principal exclusion criteria |
If any of the following applies, the patient MAY NOT enter in the study: Criteria related to the disease: • operable obstruction, • bowel obstruction that can be explained by a non malignant cause (e.g. hypokaliaemia, drug side-effects, renal insufficiency), • signs of bowel perforation, Criteria related to the studied treatment: • prior treatment with somatostatin or any analogue as treatment of the bowel obstruction in the last 60 days, • a known hypersensitivity to any of the test materials or related compounds. Other criteria • previously enrolment in this study. • female patients who are lactating or child bearing potential without adequate contraceptive measures. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Relief of clinical symptoms due to malignant bowel obstruction in inoperable patients: percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg. |
|
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |