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An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

NCT00774930 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-10-14

Study results available
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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.

Conditions

  • Carcinoid Syndrome

Interventions

DRUG

Lanreotide

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

DRUG

Placebo

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).

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-05-31
Completion
2015-12-31

Countries

  • United States
  • Brazil
  • Czechia
  • India
  • Latvia
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00774930 on ClinicalTrials.gov