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Outcome Measures

Primary Outcomes (3)

Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Baseline and 12 Weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)
Number of Participants With TEAEs in the Open-Label Extension Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.
First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)

Secondary Outcomes (3)

Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Baseline and Week 12
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Baseline and 12 Weeks
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Baseline and 12 Weeks

Study Arms (4)

250 mg Telotristat Etiprate

EXPERIMENTAL

Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

Drug: Telotristat etiprateDrug: Placebo-matching telotristat etiprate

500 mg Telotristat Etiprate

EXPERIMENTAL

Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

Drug: Telotristat etiprate

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period

Study Sites (75)

Lexicon Investigational Site

Mobile, Alabama, 36604, United States

Lexicon Investigational Site

Palo Alto, California, 94305, United States

Lexicon Investigational Site

San Francisco, California, 94115, United States

Lexicon Investigational Site

Orlando, Florida, 32806, United States

Lexicon Investigational Site

Iowa City, Iowa, 52242, United States

Lexicon Investigational Site

Lexington, Kentucky, 40536, United States

Lexicon Investigational Site

Kenner, Louisiana, 70065, United States

Related Publications (6)

Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.

PMID: 34598813DERIVED

Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.

PMID: 32157590DERIVED

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo

Telotristat Etiprate Open-Label Extension

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo

Telotristat Etiprate Open-Label Extension

You may not qualify if:

Source record

Locations