Status:
COMPLETED
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Peritoneal Neoplasms
Intestinal Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel o...
Eligibility Criteria
Inclusion
- 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
- Abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/L).
- Non authorized concomitant treatments :
- Anticholinergics such as scopolamine
- Other somatostatin analogues
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00332696
Start Date
September 1 2005
End Date
September 1 2008
Last Update
September 23 2011
Active Locations (1)
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1
Novartis Investigative Site
Créteil, France