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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ClinicalTrials.gov Identifier: NCT01076803 |
Recruitment Status :
Completed
First Posted : February 26, 2010
Last Update Posted : December 5, 2014
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Intestinal Obstruction | Drug: Lanreotide (acetate) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2009 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Lanreotide (acetate) |
Drug: Lanreotide (acetate)
Deep subcutaneous injection into the upper external quadrant of the right or the left buttock. |
- Percentage of responder patients. [ Time Frame: At day 7 and day 14. ]
- 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 ]
- Number of days without vomiting episodes [ Time Frame: 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 ]
- Intensity of abdominal pain assessed on a visual analogue scale. [ Time Frame: 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. ]
- Time between first injection and clinical response. [ Time Frame: 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076803
Belgium | |
University Hospital Ghent | |
Ghent, Belgium, 9000 |
Principal Investigator: | Karen Geboes, MD | University Hospital, Ghent |
Responsible Party: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT01076803 |
Other Study ID Numbers: |
2009/289 |
First Posted: | February 26, 2010 Key Record Dates |
Last Update Posted: | December 5, 2014 |
Last Verified: | December 2014 |
Malignant intestinal obstruction in inoperable patients |
Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Lanreotide Angiopeptin Antineoplastic Agents |