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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanreotide (acetate) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide (acetate) | Drug | Deep subcutaneous injection into the upper external quadrant of the right or the left buttock. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of responder patients. | At day 7 and day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT). | day 7, day 14 and day 28 after administration of Lanreotide | |
| Number of days without vomiting episodes | day 7, day 14 and day 28 after administration of Lanreotide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Geboes, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| website of the University Hospital Ghent | View source |
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| Number of daily nausea episodes recorded on diary cards. | day 7, day 14 and day 28 after administration of Lanreotide |
| Intensity of abdominal pain assessed on a visual analogue scale. | day 7, day 14 and day 28 after administration of Lanreotide. |
| Well-being assessed on a visual analogue scale. | day 7, day 14 and day 28 after administration of Lanreotide. |
| Time between first injection and clinical response. | day 7, day 14 and day 28 after administration of Lanreotide |
| Clinical and biological adverse events. | day 7, day 14 and day 28 after administration of Lanreotide. |
| ID | Term |
|---|---|
| C060347 | lanreotide |
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