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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012981-30-BE

Enrollment

Registered

2009-07-01

Start date

2009-08-18

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable malignant bowel obstruction MedDRA version: 9.1 Level: LLT Classification code 10006055 Term: Bowel obstruction

Interventions

Trade Name: Somatuline Autogel Injectable Product Name: Lanreotide Pharmaceutical Form: Solution for injection INN or Proposed INN: Lanreotide CAS Number: 108736352 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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: - 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 ;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.	—

Measure

Time frame

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: - 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 ;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.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026