treatment of the dumping syndrome with Lanreotide Autogel
Conditions
Interventions
Trade Name: Somatuline
Product Name: Lanreotide
Product Code: H01CB03
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
Concentration unit: mg/g milligram(s)/gram
Sponsors
Radboud University medical centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Selection on basis of the clinical diagnostic index devised by Sigstad. - In addition their dumoing score after an oral glucose challenge is positive. - patients with late dumping are selected on the basis of a history suggestive of postprandial hypoglycaemia, a plasme glucose of less than 3,0 mm/l at least 60 min after ingestion of 50 g glucose/m2 body surface and hypoglycaemic symptoms at least 60 min afetr oral glucise load. - Most patients will be on lng term octreotide LAR therapy - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with disorders of the endocrine system - Patients with severe kidney,liver or cardiovascula disease. - pregnant patients - patients giving breast feeding - patients with recent gastrointestinal surgery or other gastro-intestinal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and tolerability of L-autogel in patinets with early or late dumping after gastric surgery;Secondary Objective: ;Primary end point(s): Responses to the dumping provocation test | — |
Countries
Netherlands
Outcome results
None listed