SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

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.