Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
18 Years
N/A
Both
Intestinal Obstruction, Carcinoma, Peritoneal Neoplasms
Trial Information
Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.
Inclusion Criteria:
- digestive obstruction located in the upper part of the gastro-intestinal tract
- digestive obstruction of malignant origin
- peritoneal carcinomatosis confirmed by a CT Scan
- at least two vomiting episodes per day or a presence of a nasogastric suction tube
- inoperable patients
Exclusion Criteria:
- specific anticancer therapy within the previous 15 days
- signs of bowel perforation
- somatostatin or any analogue as treatment of the bowel obstruction
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
Outcome Time Frame:
On day 7 (plus 1 day at the latest) after the first injection
Safety Issue:
No
Principal Investigator
Sandrine Lewin
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
France: Ministry of Health
Study ID:
2-54-52030-156 (408)
NCT ID:
NCT00216372
Start Date:
September 2003
Completion Date:
October 2008
Related Keywords:
- Intestinal Obstruction
- Carcinoma
- Peritoneal Neoplasms
- carcinomatosis
- Neoplasms
- Carcinoma
- Intestinal Obstruction
- Peritoneal Neoplasms
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