CompletedPhase 2

SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Belgium24 participantsStarted 2008-04

Plain-language summary

The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the treatment of dumping syndrome.

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.

Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo.

Timeframe: at week 11 and week 27 during the study

NCT IDNCT01923649

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12-02

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.