A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00690430Tipo: INTERVENTIONALInicio: 1 de abr de 2008Fin estimado: 1 de abr de 2012

Oncología Neurología Endocrinología Gastroenterología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female patients aged 18 or greater
Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
Female patients of child bearing potential must have a negative pregnancy test at baseline.
Patients for whom written informed consent to participate in the study has been obtained.

Criterios de exclusión

Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C \> 8%
Patients with symptomatic cholelithiasis
Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.

Intervenciones

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

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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