Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (3)

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 17.1 Weeks)
Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.
Baseline and 12 Weeks
Number of Participants With Treatment-Emergent Adverse Events (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 52.6 Weeks)

Secondary Outcomes (6)

Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Baseline and 12 weeks
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Baseline and 12 Weeks
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
Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points
Baseline and 12 weeks
+1 more secondary outcomes

Study Arms (3)

250 mg Telotristat Etiprate

EXPERIMENTAL

Drug: Telotristat etiprateDrug: Placebo

500 mg Telotristat Etiprate

EXPERIMENTAL

Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.

Drug: Telotristat etiprateDrug: Placebo

Interventions

Telotristat etiprateDrug

Telotristat etiprate tablets

Also known as: LX1606

250 mg Telotristat Etiprate500 mg Telotristat Etiprate

PlaceboDrug

Placebo-matching telotristat etiprate tablets

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients ≥ 18 years of age
All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.

Sponsors & Collaborators

Lexicon Pharmaceuticals
Industrylead

Study Sites (50)

Lexicon Investigational Site

Stanford, California, 94305, 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

Boston, Massachusetts, 02215, United States

Lexicon Investigational Site

Buffalo, New York, 14263, United States

Lexicon Investigational Site

New York, New York, 10029, United States

Related Publications (3)

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
Dillon JS, Kulke MH, Horsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.
PMID: 32146619DERIVED

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

telotristat

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Results Point of Contact

Title: Pablo Lapuerta, MD
Organization: Lexicon Pharmaceuticals, Inc.

Study Officials

Pablo Lapuerta, MD
Lexicon Pharmaceuticals, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

March 11, 2014

Actual (reported)

Telotristat Etiprate for Carcinoid Syndrome Therapy

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 (6)

Study Arms (3)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo

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 (6)

Study Arms (3)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (50)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations