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Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

NCT ID: NCT01076803

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-07-31

Brief Summary

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The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg.

(A responder patient will be defined either as a patient experiencing \< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days)

The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28

Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample

Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication

In between the visits, the patient will keep and fill out his diary and VAS scale

Detailed Description

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Conditions

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Malignant Intestinal Obstruction

Keywords

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Malignant intestinal obstruction in inoperable patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lanreotide (acetate)

Group Type EXPERIMENTAL

Lanreotide (acetate)

Intervention Type DRUG

Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.

Interventions

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Lanreotide (acetate)

Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PIC
* \>= 18 years at time of enrolment
* Diagnosis of a digestive obstruction of malignant origin
* Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months
* Inoperability as decided after surgical consultation

Exclusion Criteria

* Operable obstruction
* Bowel obstruction that can be explained by a non malignant cause
* Signs of bowel obstruction
* Prior treatment with somatostatin analogues within the previous 60 days
* Known hypersensitivity to any of the test materials or related compounds
* Previous enrolment in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Geboes, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website of the University Hospital Ghent

Other Identifiers

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2009/289

Identifier Type: -

Identifier Source: org_study_id