NCT00774930: ELECT

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

Completed Phase 3 Results posted Last updated 15 September 2022

What this trial tests

Phase 3 trial testing Lanreotide in Carcinoid Syndrome in 115 participants. Completed in 1 December 2015.

Timeline

1 May 2009

Primary endpoint
1 May 2013

1 December 2015

Quick facts

Lead sponsor	Ipsen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	115
Start date	1 May 2009
Primary completion	1 May 2013
Estimated completion	1 December 2015
Sites	54 locations across United States, Brazil, Czechia, India, Latvia, Poland, Russia, Serbia

Drugs / interventions tested

• Lanreotide (LANREOTIDE) — full drug profile →
• Placebo

Conditions studied

• Carcinoid Syndrome — all drugs for Carcinoid Syndrome →

Sponsor

Ipsen — full company profile →

Who can join

18 and older, any sex, with Carcinoid 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.

• Percentage of Days With Subcutaneous Octreotide as Rescue Medication
  Time frame: 16-week DB phase
  Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. EVALUATION OF LANREOTIDE DEPOT/AUTOGEL EFFICACY AND SAFETY AS A CARCINOID SYNDROME TREATMENT (ELECT): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL.
   Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, et al · · 2016 · cited 69× · PMID 27214300 · DOI 10.4158/ep151172.or
2. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.
   Martín-Richard M, Massutí B, Pineda E, Alonso V, et al · · 2013 · cited 54× · PMID 24053191 · DOI 10.1186/1471-2407-13-427
3. Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel: Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study.
   Fisher GA, Wolin EM, Liyanage N, Pitman Lowenthal S, et al · · 2018 · cited 21× · PMID 29038234 · DOI 10.1634/theoncologist.2017-0284
4. Medical treatment for gastro-entero-pancreatic neuroendocrine tumours.
   Berardi R, Morgese F, Torniai M, Savini A, et al · · 2016 · cited 15× · PMID 27096034 · DOI 10.4251/wjgo.v8.i4.389
5. Clinical and Preclinical Advances in Gastroenteropancreatic Neuroendocrine Tumor Therapy.
   Crabtree JS. · · 2017 · cited 9× · PMID 29255447 · DOI 10.3389/fendo.2017.00341
6. A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial.
   Blot K, Duchateau L, Lescrauwaet B, Liyanage N, et al · · 2019 · cited 2× · PMID 31754316 · DOI 10.2147/prom.s219982