NCT00332696

Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 obstruction in patients with peritoneal carcinomatosis

Conditions

• Peritoneal Neoplasms
• Intestinal Obstruction
• Carcinomatosis

Interventions

Type	Name	Description
DRUG	Octreotide LAR	Octreotide long-acting release (LAR) 30 mg intramuscular injection.
DRUG	Octreotide (Immediate release)	Immediate-release Octreotide supplied in 100 µg/mL ampules.
DRUG	methylprednisolone	methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
DRUG	Placebo	Physiologic saline solution

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-06-02
• Last updated: 2011-09-23
• Results posted: 2011-06-15

Locations

1 site across 1 country: France