NCT01923649

SOMATULINE Autogel 90 mg IN DUMPING SYNDROME

Completed Phase 2 Last updated 26 January 2023

What this trial tests

Phase 2 trial testing Lanreotide 90 mg slow release formulation in Dumping Syndrome in 24 participants. Completed in 2 December 2013.

Timeline

1 April 2008

Primary endpoint
2 December 2013

2 December 2013

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	1 April 2008
Primary completion	2 December 2013
Estimated completion	2 December 2013
Sites	3 locations across Belgium

Drugs / interventions tested

• Lanreotide 90 mg slow release formulation — full drug profile →
• Placebo

Conditions studied

• Dumping Syndrome — all drugs for Dumping Syndrome →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 18 to 100, any sex, with Dumping Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo.
  Time frame: at week 11 and week 27 during the study
  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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of lanreotide in postoperative dumping syndrome: A Phase II randomised and placebo-controlled study.
   Wauters L, Arts J, Caenepeel P, Holvoet L, et al · · 2019 · cited 12× · PMID 31662863 · DOI 10.1177/2050640619862166