EUCTR2009-012981-30-BE
Active, not recruiting
Phase 1
Prospective study to assess the efficacy and safety of lanreotide 120 mg as treatment of clinical symptoms associated with inoperable intestinal obstruction
niversity Hospital Ghent0 sites40 target enrollmentJuly 1, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Inoperable malignant bowel obstruction
- Sponsor
- niversity Hospital Ghent
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient MUST satisfy ALL of the following inclusion criteria before he/she will be allowed to participate in the study:
- •Patient have to give written (personally signed and dated) informed consent before completing any study\-related procedure.
- •Demographic criteria
- •\=18 years of age.
- •Criteria related to the disease
- •diagnosis of a digestive obstruction of malignant origin, confirmed by a CT scan within the previous 3 months,
- •inoperability as decided after surgical consultation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •If any of the following applies, the patient MAY NOT enter in the study:
- •Criteria related to the disease:
- •operable obstruction,
- •bowel obstruction that can be explained by a non malignant cause (e.g. hypokaliaemia, drug side\-effects, renal insufficiency),
- •signs of bowel perforation,
- •Criteria related to the studied treatment:
- •prior treatment with somatostatin or any analogue as treatment of the bowel obstruction in the last 60 days,
- •a known hypersensitivity to any of the test materials or related compounds.
- •Other criteria
- •previously enrolment in this study.
Outcomes
Primary Outcomes
Not specified
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