Prospective study to assess the efficacy and safety of lanreotide 120 mg as treatment of clinical symptoms associated with inoperable intestinal obstructio

Phase 1

• Conditions: Inoperable malignant bowel obstruction; MedDRA version: 9.1Level: LLTClassification code 10006055Term: Bowel obstruction

• Registration Number: EUCTR2009-012981-30-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-01
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients.;Secondary Objective: To assess the efficacy of lanreotide 120 mg in terms of:<br> - Number of daily vomiting episodes recorded on diary cards or measurement of the daily drainage by nasoogastric tube (NGT),<br> - Number of days without vomiting episodes, <br> - Number of daily nausea episodes recorded on diary cards,<br> - Intensity of abdominal pain assessed on a visual analogue scale,<br> - Well-being assessed on a visual analogue scale,<br> - Time between first injection (inclusion) and clinical response,<br>To assess the clinical and biological safety of the treatment<br>;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.