Dumping Syndrome Patients Clinical Trial
Official title:
A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
43 adult patients with dumping syndrome will receive 3 months of pasireotide s.c. during the dose escalation phase (dose can be increased based on the presence of hypoglycemia during OGTT). From Month 3- to Month 6 patients will then switch to pasireotide LAR. The core phase of the study is completed at tghe end of Month 6. Patients will be offered to enter into the 6 month extension phase if they experienced benefit with pasireotide LAR treatment ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment