Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

Exclusion Criteria

• •Patients who have undergone major surgery/surgical therapy for any cause within 1 month
• •Patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old).
• •Patients who have failed treatment with somatostatin analogues in the past (specifically patients who have been treated with octreotide s.c. for more than 2 days or with a long acting somatostatin analogue for more than 8 weeks).
• •Patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.
• •Patients who have a known hypersensitivity to somatostatin analogues.
• •Patients with the diagnosis of Diabetes Mellitus
• •Patients with important co-morbidity (cardiac, pulmonary, renal , hepatic diseases)
• •Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
• •Patients receiving anticoagulants that affect PT or PTT
• •Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condoms. If oral contraception is used, the patient must have been practicing this method for at least three months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for 3 months afterwards.
• •History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
• •Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
• •Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
• •Patients with the presence of active or suspected acute or chronic uncontrolled infection
• •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study