dumping syndrome MedDRA version: 9.1 Level: LLT Classification code 10013810 Term: Dumping syndrome
Conditions
Interventions
Product Name: Pasireotide
Product Code: SOM230B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-77-3
Other descriptive name: SOM230
Concentration unit:
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Double-blind cross-over phase: • Male or female patients aged between 18 and 80 years. • Patients with diagnosis of Dumping Syndrome: • Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score =10) AND o either (a) having had a documented episode of postprandial hypoglycemia in the medical history o or either (b) demonstrating a hypoglycemia ( 3% or a pulse increase of 10 bpm after an oral glucose tolerance test with 75 g of glucose. • Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period B. Inclusion in the open label phase is based on an equal or more than 20% improvement with SOM230 s.c. versus placebo s.c. in Dumping Syndrome Symptom Score during the double-blind phase, independent in which period they were in the active arm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of pasireotide for the control of symptoms related to the Dumping Syndrome (Early and Late dumping symptoms) in the double-blind cross-over phase 2. To evaluate efficacy of different dose regimens in the open label phase THE TRIAL WILL BE SUBMITTED AS A DOUBLE-BLIND STUDY AND WILL BE AS SUCH COMPLETED IN THIS CLINICAL TRIAL FORM (the main phase is the double-blind cross-over phase, where the open label phase is just a FU of the patients under different doses);Secondary Objective: 3. To evaluate the efficacy of pasireotide for the control of objective parameters of Dumping Syndrome a) To assess the effect of pasireotide (sst1, 2, 3, 5) on control of gastric emptying b) To assess the effect of pasireotide (sst1, 2, 3, 5) on the release of GI hormones c) To assess the effect of pasireotide (sst1, 2, 3, 5) on the hyperinsulimic response 4. To assess the overall safety and tolerability of pasireotide in this patient population 5. To assess the effect of pasireotide on quality of life (QoL SF-36) 6. To assess safety ;Primary end point(s): impact on symptoms related to Dumping Syndrome | — |
Countries
Belgium
Outcome results
None listed