SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Phase 1

• Conditions: dumping syndrome; MedDRA version: 9.1Level: LLTClassification code 10013810Term: Dumping syndrome

• Registration Number: EUCTR2008-000643-34-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-17
• Study Completion: 2013-11-15
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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.

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 efficacy of Somatuline 90 mg versus placebo in the treatment of dumping syndrome by using a specific Treatment Assessment Scale and a specific dumping score.<br><br>;Secondary Objective: 1.To assess the effect of Somatuline 90 mg versus placebo on a quality of life (QOL) questionnaire. (SF-36)<br>2.To assess the tolerability of Somatuline 90 mg versus placebo.<br>;Primary end point(s): To assess the efficacy of Somatuline 90 mg versus placebo in the treatment of dumping syndrome by using a specific Treatment Assessment Scale and a specific dumping score.