Postoperative Dumping Syndrome Clinical Trial
Official title:
Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
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)
This will be a single centre, randomized, double-blind, controlled cross-over study during
35 days.
After a 4 weeks screening period, patients who fulfill the entrance criteria will be
randomly assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo
treatment arm. They will be treated with pasireotide sc or placebo sc for 2 weeks. After 2
weeks, patients will be switched to the other treatment arm after a 7 days wash out period.
This phase is double-blind: both the patient and investigator will be blinded to treatment
assignment.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment