AN INTERNATIONAL, MULTICENTRIC, PROSPECTIVE, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG ASSOCIATED TO STANDARD OF CARE IN THE TREATMENT OF CLINICAL SYMPTOMS ASSOCIATED WITH INOPERABLE MALIGNANT INTESTINAL OBSTRUCTIO

Phase 1

• Conditions: Inoperable malignant intestinal obstruction; MedDRA version: 19.0Level: LLTClassification code 10022690Term: Intestinal obstruction NOSSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-002174-43-BE
• Lead Sponsor: IPSEN NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-24
• Study Completion: 2017-11-09
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1) Written informed consent before any study related procedure
2) Male and female patients age 18 years or older at the time of enrolment
3) Diagnosis of an intestinal obstruction of malignant origin
4) In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study
5) Confirmed as inoperable after surgical advice
6) Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours
7) Estimated life expectancy 1 month or more

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1) Operable obstruction or any subobstruction
2) Bowel obstruction due to a non-malignant cause (for example : hypokaliaemia, drug side-effects, renal insufficiency, …)
3) Signs of bowel perforation
4) Prior treatment with somatostatin or any analogue within the previous 60 days
5) A known hypersensitivity to any of the study treatments or related compounds
6) Previous participation in this study
7) Is likely to require treatment during the study with drugs that are not permitted
by the study protocol (see Section 9.5).
8) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified