SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000643-34-BE

Enrollment

Registered

2008-03-17

Start date

2008-04-25

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dumping syndrome MedDRA version: 9.1 Level: LLT Classification code 10013810 Term: Dumping syndrome

Interventions

Trade Name: Somatuline Autogel 90 mg® (lanreotide) Pharmaceutical Form: Gel for injection CAS Number: 108736352 Other descriptive name: Lanreotide 90 mg Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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.

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: 1. To assess the effect of Somatuline 90 mg versus placebo on a quality of life (QOL) questionnaire. (SF-36) 2. To assess the tolerability of Somatuline 90 mg versus placebo. ;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.	—

Measure

Time frame

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. ;Secondary Objective: 1. To assess the effect of Somatuline 90 mg versus placebo on a quality of life (QOL) questionnaire. (SF-36) 2. To assess the tolerability of Somatuline 90 mg versus placebo. ;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.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026