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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

Brief Summary:

Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate :

  • the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.
  • the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT).
  • the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT).
  • the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)
  • the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score
  • the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately
  • the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)