Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
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)