Dumping Syndrome Clinical Trial
Official title:
SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
Verified date | July 2017 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2, 2013 |
Est. primary completion date | December 2, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Patients with clinical suspect of a dumping syndrome with a total dumping score* (early and late symptoms) = 10, and 1. 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 2. 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) Exclusion Criteria: 1. Patients who have been treated with Somatuline or Sandostatine LAR in the past 2. Cholecystolithiasis 3. Diabetes Mellitus 4. Coeliakie and Giardia 5. Untreated severe oesophagitis 6. Untreated 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 lanreotide or one of the compounds of the drug. |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ St. Lucas | Brugges | |
Belgium | ZOL Genk | Genk | |
Belgium | University Hospitals Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | Ipsen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo. | Early dumping starts immediately after a meal, within 1 hour (< 1 hour). Late dumping starts later than 1 hour after a meal (= 1 hour). Each item is scored from zero (not present) 1 (mild) , 2 (moderate) and 3 (severe). Early dumping symptoms : sweating, flushes, dizziness, palpitations, abdominal pain, diarrhea, bloating, nausea. Late dumping symptoms : sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression.
The change in dumping score will be assessed after 11 weeks and a second time after cross over at week 27. Additionally, the overall improvement is assessed by asking "how do you feel compared with your situation before starting the study at week 11. The same question is asked at week 27. Additionally at week 27 the following question is asked " How do you feel compared with your situation 4 months ago ?" Scoring is done on a 7 point Likert scale. |
at week 11 and week 27 during the study | |
Secondary | Change in quality of life. | To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36). | week 0, 11, 16 and 27 | |
Secondary | The difference in number of participants with adverse events between somatuline 90 mg versus placebo | To assess the tolerability of Somatuline 90 mg versus placebo. | at week 27 (end of the study) |
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