Sandostatine LAR in Dumping syndrome - Dumping Syndrome
- Conditions
- Dumping Syndrome is a condition characterized by weakness, dizziness, flushing and warmth, nausea and palpitation immediately or shortly after eating and produced by abnormally rapid emptying of the stomach in persons who have had part of the stomach removed or in hypersensitive or neurotic individuals
- Registration Number
- EUCTR2005-003250-98-BE
- Lead Sponsor
- Z LEUVE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) > 10, and a. 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 b. documented spontaneous hypoglycemia (at least 1) 2. Age > 18 years 3. 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)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
1. Patients who haven’t been treated with Sandostatine during the last 6 months. 2. Cholecystolithiasis 3. Diabetes Mellitus 4. Coeliakie and Giardia 5. Severe oesophagitis 6. Gastric and duodenum ulcer 7. 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). 8. Hypersensitivity to octreotide or one of the compounds of the drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of Sandostatine LAR on a specific Patient Assessment Scale and on a specific dumping score in patients tolerating well Sandostatine subcutaneously.;Secondary Objective: Secondary objectives : 1. To assess the effect of Sandostatine s.c. on an oral glucose tolerance test (OGTT). 2. To assess the effect of Sandostatine LAR on OGTT. 3. To assess the effect of Sandostatine LAR on a quality of life (QOL) questionnaire. 4. To assess the tolerability of Sandostatine LAR;Primary end point(s): Evaluation of the effect of Sandostatin® LAR in patients with dumping syndrome who tolerates well Sandostatine® s.c. via a patient assessment scale and dumping score table
- Secondary Outcome Measures
Name Time Method