Status:
COMPLETED
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Lead Sponsor:
Ipsen
Conditions:
Intestinal Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to assess the efficacy ...
Eligibility Criteria
Inclusion
- Written informed consent before any study related procedure
- Male and female patients age 18 years or older at time of enrollment
- Diagnosis of intestinal obstruction of malignant origin
- In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study
- Confirmed as inoperable after surgical advice
- Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours
- Estimated life expectancy 1 month or more
Exclusion
- Operable obstruction or subobstruction
- Bowel obstruction due to a non-malignant cause
- Signs of bowel perforation
- Prior treatment with somatostatin or any other analogue within the previous 60 days
- A known hypersensitivity to any of the study treatments or related compounds
- Previous participation in this study
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety
Key Trial Info
Start Date :
November 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02275338
Start Date
November 19 2014
End Date
November 9 2017
Last Update
April 16 2019
Active Locations (17)
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1
Aalst, Belgium
2
Antwerp, Belgium
3
Bruges, Belgium
4
Ste-Elisabeth Hospital
Brussels, Belgium