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Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

NCT00690430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2013-07-30

Study results available
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Summary

The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

Conditions

  • Symptomatic Refractory Resistant Carcinoid Disease

Interventions

DRUG

Pasireotide

Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed

DRUG

Octreotide

Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Norway
  • Poland
  • Singapore
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00690430 on ClinicalTrials.gov