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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

Primary Purpose

Malignant Intestinal Obstruction

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Lanreotide (acetate)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Intestinal Obstruction focused on measuring Malignant intestinal obstruction in inoperable patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lanreotide (acetate)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of responder patients.

Secondary Outcome Measures

Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric 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 and clinical response.
Clinical and biological adverse events.

Full Information

First Posted
December 2, 2009
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01076803
Brief Title
Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Intestinal Obstruction
Keywords
Malignant intestinal obstruction in inoperable patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide (acetate)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lanreotide (acetate)
Intervention Description
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
Primary Outcome Measure Information:
Title
Percentage of responder patients.
Time Frame
At day 7 and day 14.
Secondary Outcome Measure Information:
Title
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
Title
Number of days without vomiting episodes
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide
Title
Number of daily nausea episodes recorded on diary cards.
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide
Title
Intensity of abdominal pain assessed on a visual analogue scale.
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide.
Title
Well-being assessed on a visual analogue scale.
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide.
Title
Time between first injection and clinical response.
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide
Title
Clinical and biological adverse events.
Time Frame
day 7, day 14 and day 28 after administration of Lanreotide.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Geboes, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website of the University Hospital Ghent

Learn more about this trial

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

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