A single center trial with a randomized, double-blind, placebo-controlled phase to assess safety and efficacy of sc pasireotide in patients with dumping syndrome, followed by an open label phase on active medication. - SOM230 in Dumping Syndrome

Phase 1

• Conditions: dumping syndrome; MedDRA version: 9.1Level: LLTClassification code 10013810Term: Dumping syndrome

• Registration Number: EUCTR2008-000700-84-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-02
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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
oeither (a) having had a documented episode of postprandial hypoglycemia in the medical history
oor 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.

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified