CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
Lanreotide +1 moredrug
Likely dose
Lanreotide 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00774930
NCT00774930Phase 3Completed

A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Ipsen·interventional·Posted Oct 17, 2008·Updated Oct 14, 2022

In Brief

A Phase 3 clinical trial evaluating Lanreotide and Placebo for Carcinoid Syndrome. Completed, enrolled 115 participants across 54 sites in 11 countries.

Detailed Summary

The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Czechia, India, Latvia, Poland, Russia, Serbia, South Africa, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartMay 1, 2009
Primary CompletionMay 1, 2013
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.7 years ago

Interventions

Lanreotidedrug

deep s.c. injection, 120 mg, every 4 weeks (±3 days).

Placebodrug

deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).