SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
Dumping Syndrome
About this trial
This is an interventional treatment trial for Dumping Syndrome focused on measuring postoperative dumping, somatostatin analogues, somatulin, lanreotide, dumping syndrome
Eligibility Criteria
Inclusion Criteria:
Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) ≥ 10, and
- a positive OGTT, in terms of a glycemia <60 mg/dl or Hematocrit increase > 3%, or an increase of pulse rate by 10 bpm Or
- documented spontaneous hypoglycemia (at least 1)
- Age > 18 years
- Diet of 6 meals a day with low concentration of mono- and disaccharides during 1 month before inclusion without sufficient improvement (= evaluation by physician and patient)
Exclusion Criteria:
- Patients who have been treated with Somatuline or Sandostatine LAR in the past
- Cholecystolithiasis
- Diabetes Mellitus
- Coeliakie and Giardia
- Untreated severe oesophagitis
- Untreated gastric and duodenum ulcer
- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Hypersensitivity to lanreotide or one of the compounds of the drug.
Sites / Locations
- AZ St. Lucas
- ZOL Genk
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lanreotide slow release 90 mg
Placebo
Patients receive lanreatide slow release (Somatuline autogel) 90 mg every four weeks via a deep subcutaneous injection, three times. After a wash out period of 4 weeks they receive a similar placebo every for weeks, three times.
Patients receive a deep subcutanous injection of placebo every four weeks, three times. After a wash out of three weeks, they will receive somatuline 90 mh via a deep subcutanous injection every four weeks, three times.