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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00774930
First received: October 15, 2008
Last updated: February 26, 2014
Last verified: February 2014

October 15, 2008
February 26, 2014
March 2009
May 2013   (final data collection date for primary outcome measure)
Usage of subcutaneous octreotide to control symptoms associated with carcinoid syndrome, measured as the % of days that subcutaneous octreotide is used as rescue medication based on patient Interactive Voice Response System ( IVRS) diary records [ Time Frame: 16 week double-blind phase of the study ] [ Designated as safety issue: No ]
Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, during the 16-week double-blind phase of the study based on patient IVRS diary records [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00774930 on ClinicalTrials.gov Archive Site
  • Frequency of diarrhea events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Frequency of flushing events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Usage of other rescue medications for diarrhea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Changes from baseline in Quality of Life (QoL); assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30-Carcinoid/NETs module: EORTC QLQ-G.I. NET 21 [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
  • Absolute changes from baseline in biochemical marker - urinary 5-hydroxyindoleacetic acid (5-HIAA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Carcinoid Syndrome
  • Drug: Somatuline Depot (lanreotide)
    subcutaneous injection, 120 mg, q28d
    Other Name: Somatuline Autogel
  • Drug: placebo
    inactive substance
  • Experimental: Somatuline Depot 120 mg
    Intervention: Drug: Somatuline Depot (lanreotide)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
December 2015
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of unknown location with liver metastases
  • history of carcinoid syndrome (flushing and/or diarrhea)
  • either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
  • confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
  • absence of tumor progression

Exclusion Criteria:

  • history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
  • treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
  • history of hepatic arterial embolization
  • short bowel syndrome
  • uncontrolled diabetes and/or hypertension
  • severe renal impairment and/or liver impairment
  • diagnosis of cardiac disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Czech Republic,   India,   Latvia,   Poland,   Russian Federation,   Serbia,   South Africa,   Turkey,   Ukraine
 
NCT00774930
2-55-52030-730, TR321, 2010-019066-92
Yes
Ipsen
Ipsen
Not Provided
Study Director: Edda Gomez-Panzani, M.D. Ipsen
Ipsen
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP