Treatment of dumping syndrome with Lanreotide Autogel
- Conditions
- treatment of the dumping syndrome with Lanreotide Autogel
- Registration Number
- EUCTR2007-001078-94-NL
- Lead Sponsor
- Radboud University medical centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>
- Secondary Outcome Measures
Name Time Method