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

NCT00332696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-09-23

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00332696 on ClinicalTrials.gov