Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
18 Years
N/A
Both
Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
Trial Information
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Inclusion Criteria:
- Patients with symptoms and signs of inoperable bowel obstruction confirmed by a
surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
- Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery,
imaging and/or cytology);
- No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the
previous 2 weeks ;
- No chemotherapy in the previous week;
- No radio or chemotherapy planned at the inclusion and within the two weeks following
inclusion
- Authorized concomitant treatments for local standard medical care : antiemetics,
antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor,
analgesics; nasogastric tube
Exclusion Criteria:
- Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).
- Non authorized concomitant treatments :
1. Anticholinergics such as scopolamine
2. Other somatostatin analogues
Other protocol-defined inclusion/exclusion criteria may apply
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:
Number of Participants With Treatment Success From Day 10 to Day 13
Outcome Description:
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
Outcome Time Frame:
Day 10 to Day 13
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CSMS995AFR08
NCT ID:
NCT00332696
Start Date:
September 2005
Completion Date:
September 2008
Related Keywords:
- Peritoneal Neoplasms
- Intestinal Obstruction
- Carcinomatosis
- bowel obstruction,
- peritoneal carcinomatosis
- Octreotide
- inoperable
- Neoplasms
- Intestinal Obstruction
- Peritoneal Neoplasms
- Carcinoma
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