Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction (IMIO)

Ipsen

Status and phase: Completed; Phase 2

Conditions: Intestinal Obstruction

Treatments: Drug: Lanreotide Autogel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275338

2013-002174-43 (EudraCT Number)

A-48-52030-269

Details and patient eligibility

About

To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Operable obstruction or subobstruction
• Bowel obstruction due to a non-malignant cause
• Signs of bowel perforation
• Prior treatment with somatostatin or any other analogue within the previous 60 days
• A known hypersensitivity to any of the study treatments or related compounds
• Previous participation in this study
• Is likely to require treatment during the study with drugs that are not permitted by the study protocol
• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Lanreotide Autogel

Experimental group

Description:

120mg administered via deep subcutaneous injection at Day 0 and Day 28.

Treatment:

Drug: Lanreotide Autogel