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

December 4, 2014 updated by: University Hospital, Ghent

Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lanreotide (acetate)
Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of responder patients.
Time Frame: At day 7 and day 14.
At day 7 and day 14.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT).
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide
day 7, day 14 and day 28 after administration of Lanreotide
Number of days without vomiting episodes
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide
day 7, day 14 and day 28 after administration of Lanreotide
Number of daily nausea episodes recorded on diary cards.
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide
day 7, day 14 and day 28 after administration of Lanreotide
Intensity of abdominal pain assessed on a visual analogue scale.
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide.
day 7, day 14 and day 28 after administration of Lanreotide.
Well-being assessed on a visual analogue scale.
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide.
day 7, day 14 and day 28 after administration of Lanreotide.
Time between first injection and clinical response.
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide
day 7, day 14 and day 28 after administration of Lanreotide
Clinical and biological adverse events.
Time Frame: day 7, day 14 and day 28 after administration of Lanreotide.
day 7, day 14 and day 28 after administration of Lanreotide.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Karen Geboes, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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