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Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

NCT00853047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-12-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.

Conditions

  • Carcinoid Syndrome

Interventions

DRUG

Telotristat etiprate

Telotristat etiprate capsules; orally 3 times daily.

DRUG

Octreotide LAR Depot

A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.

DRUG

Placebo

Placebo-matching telotristat etiprate capsules; orally 3 times daily.

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Pablo Lapuerta, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00853047 on ClinicalTrials.gov