E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013810 |
E.1.2 | Term | Dumping syndrome |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (<60mg/dl) or hematocrite increase of > 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
impact on symptoms related to Dumping Syndrome
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |