A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Inclusion Criteria:

- histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of
unknown location with liver metastases

- history of carcinoid syndrome (flushing and/or diarrhea)

- either naive to treatment with a Somatostatin analog or responsive to conventional
doses of LAR or subcutaneous octreotide

- confirmation of positive somatostatin receptor status by somatostatin receptor
scintigraphy

- absence of tumor progression

Exclusion Criteria:

- history of carcinoid syndrome refractory to treatment with conventional doses of
Somatostatin analogs

- treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled
Somatostatin analog and/or tumor debulking < 3 months prior to study entry

- history of hepatic arterial embolization

- short bowel syndrome

- uncontrolled diabetes and/or hypertension

- severe renal impairment and/or liver impairment

- diagnosis of cardiac disease