Carcinoid SyndromePhase 3TELECASTNCT02063659

Telotristat Etiprate for Carcinoid Syndrome Therapy

A Phase 3 study testing Telotristat etiprate in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 50 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoid Syndrome
What is being tested?: Telotristat etiprate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 50 sitesin 11 countries
Study dates: 11 Mar 2014to 29 Mar 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
Documented history of carcinoid syndrome
Patient is able and willing to provide written informed consent prior to participation

Who cannot join

Presence of diarrhea attributed to any condition other than carcinoid syndrome.
Presence of 12 or more watery bowel movements per day
Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
Karnofsky Performance Status ≤ 60%
Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
A history of short bowel syndrome
History of constipation within 2 years of Screening
Life expectancy < 12 months from Screening

Trial locations and contacts

50 sites in 11 countries.

Country

City, postcode or hospital

50 sites in 11 countries

Germany9 sites

Lexicon Investigational Site
Bad Berka, 99437
Lexicon Investigational Site
Berlin, 13353
Lexicon Investigational Site
Hamburg, 20246
Lexicon Investigational Site
Heidelberg, 69120
Lexicon Investigational Site
Lübeck, 23538
Lexicon Investigational Site
Mainz, 55131
Lexicon Investigational Site
Marburg, 35043
Lexicon Investigational Site
Munich, 81377
Lexicon Investigational Site
Neuss, 41464

Other trials in Germany

United States8 sites

Lexicon Investigational Site
Boston, Massachusetts, 02215
Lexicon Investigational Site
Buffalo, New York, 14263
Lexicon Investigational Site
Iowa City, Iowa, 52242
Lexicon Investigational Site
Lexington, Kentucky, 40536
Lexicon Investigational Site
New York, New York, 10029
Lexicon Investigational Site
Orlando, Florida, 32806
Lexicon Investigational Site
Philadelphia, Pennsylvania, 19104
Lexicon Investigational Site
Stanford, California, 94305

Other trials in United States

United Kingdom7 sites

Lexicon Investigational Site
Basingstoke Hampshire, RG249NA
Lexicon Investigational Site
Coventry, CV22DX
Lexicon Investigational Site
London, NW3 2QG
Lexicon Investigational Site
London, SE59RS
Lexicon Investigational Site
London, W12 OHS
Lexicon Investigational Site
Manchester, M204BX
Lexicon Investigational Site
Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

France6 sites

Lexicon Investigational Site
Clichy, 92118
Lexicon Investigational Site
Lille, 59037
Lexicon Investigational Site
Lyon, 69347
Lexicon Investigational Site
Marseille, 13385
Lexicon Investigational Site
Strasbourg, 67098
Lexicon Investigational Site
Villejuif, 94805

Other trials in France

Spain5 sites

Lexicon Investigational Site
Barcelona, 08035
Lexicon Investigational Site
Barcelona, 08907
Lexicon Investigational Site
Madrid, 28034
Lexicon Investigational Site
Madrid, 28040
Lexicon Investigational Site
Seville, 41013

Other trials in Spain

Australia4 sites

Lexicon Investigational Site
East Melbourne, Victoria, 3002
Lexicon Investigational Site
Herston, Queensland, 4029
Lexicon Investigational Site
Kogara, New South Wales, 2217
Lexicon Investigational Site
St Leonards, New South Wales, 2065

Other trials in Australia

Netherlands4 sites

Lexicon Investigational Site
Amsterdam, North Holland, 1066X
Lexicon Investigational Site
Amsterdam, North Holland, 1105 AZ
Lexicon Investigational Site
Noord Brahant, 5631BM
Lexicon Investigative Site
Rotterdam, 3015 CE

Other trials in Netherlands

Belgium3 sites

Lexicon Investigational Site
Edegem, B-2650
Lexicon Investigational Site
Ghent, 9000
Lexicon Investigational Site
Yvoir, 5530

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Canada2 sites

Lexicon Investigational Site
Calgary, Alberta, T2N4N2
Lexicon Investigational Site
Halifax, Nova Scotia, B0J1N0

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Israel1 site

Lexicon Investigational Site
Jerusalem, 91120

Other trials in Israel

Sweden1 site

Lexicon Investigational Site
Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Conditions: Carcinoid Syndrome
Being tested: Telotristat etiprate, Placebo
Medical subject headings: Serotonin Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telotristat etiprateDrug
Also called LX1606
Telotristat etiprate tablets
PlaceboDrug
Placebo-matching telotristat etiprate tablets

Study groups in NCT02063659
Study group	Role	What they receive
250 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 12 weeks, followed by a 36 week open-label extension period. Receives: Drug: Telotristat etiprate; Drug: 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. Receives: Drug: Telotristat etiprate; Drug: Placebo
Placebo	Placebo comparator	Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline and 12 weeks
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.
Measured: Baseline and 12 Weeks
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Measured: Baseline and 12 Weeks
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.
Measured: 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
The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.
Measured: Baseline and 12 weeks
Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline
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.
Measured: Baseline and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201429 Mar 2016

First posted14 Feb 2014 (estimated)
Study start11 Mar 2014
Primary completion29 Mar 2016
Study completion29 Mar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063659
Sponsor's protocol ID: LX1606.1-303-CS
Other IDs: LX1606.303, 2013-001543-31
Acronym: TELECAST
Status last verified: Jan 2018
First submitted: 12 Feb 2014
Last updated: 26 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 34598813
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.
PubMed 32146619
Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Horsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.
PubMed 29330194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoid Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
ClinicalTrials.gov ID: NCT02063659
Acronym / sponsor ID: TELECAST / LX1606.1-303-CS
Conditions: Carcinoid Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 11 Mar 2014 (actual)
Primary completion: 29 Mar 2016 (actual)
Study completion: 29 Mar 2016 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 25 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
250 mg Telotristat Etiprate	Experimental	Drug: Telotristat etiprate, Drug: PlaceboFollowing 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 12 weeks, followed by a 36 week open-label extension period.
500 mg Telotristat Etiprate	Experimental	Drug: Telotristat etiprate, Drug: PlaceboFollowing 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.
Placebo	Placebo comparator	Drug: PlaceboFollowing a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
Documented history of carcinoid syndrome
Patient is able and willing to provide written informed consent prior to participation

Key exclusion criteria (8 listed)

Presence of diarrhea attributed to any condition other than carcinoid syndrome.
Presence of 12 or more watery bowel movements per day
Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
Karnofsky Performance Status ≤ 60%
Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telotristat etiprateAlso: LX1606Telotristat etiprate tablets	Drug	250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate
PlaceboPlacebo-matching telotristat etiprate tablets	Drug	250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate, Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period
Time frame: 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)
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.
Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels
Time frame: Baseline and 12 Weeks
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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period
Time frame: 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)
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.

6 secondary outcomes

Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points
Time frame: Baseline and 12 Weeks
Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points
Time frame: Baseline and 12 Weeks
Change From Baseline in Abdominal Pain Averaged Across All Time-Points
Time frame: 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
Time frame: Baseline and 12 weeks
Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline
Time frame: Baseline and 12 Weeks

Results and safety

Results posted to the registry on 25 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	26	24
250 mg Telotristat Etiprate	25	22
500 mg Telotristat Etiprate	25	22
Telotristat Etiprate Open-Label Extension	0	0

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period

Time frame: 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). Count of participants. Unit: Participants

Measure	Placebo n = 26	250 mg Telotristat Etiprate n = 25	500 mg Telotristat Etiprate n = 25
Value	21	25	22

Population analysed: Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.

Primary outcome: Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: percentage change of mg/24 hours

Measure	Placebo n = 22	250 mg Telotristat Etiprate n = 17	500 mg Telotristat Etiprate n = 19
Value	97.721 (397.0107)	-33.164 (58.4754)	-76.466 (17.3714)

Placebo vs 250 mg Telotristat Etiprate: Hodges-Lehman estimator of difference: -53.955 (95% CI -84.955 to -25.119), p < 0.001, Wilcoxon rank sum
Placebo vs 500 mg Telotristat Etiprate: Hodges-Lehman estimator of difference: -89.662 (95% CI -113.104 to -63.863), p < 0.001, Wilcoxon rank sum

Population analysed: Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period

Time frame: 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). Count of participants. Unit: Participants

Measure	Telotristat Etiprate Open-Label Extension n = 67
Value	61

Population analysed: Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 26 (19.2%)	21 of 26 (80.8%)	0 of 26
250 mg Telotristat Etiprate	1 of 25 (4%)	25 of 25 (100%)	0 of 25
500 mg Telotristat Etiprate	3 of 25 (12%)	22 of 25 (88%)	0 of 25
Telotristat Etiprate Open-Label Extension	17 of 67 (25.4%)	61 of 67 (91%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34598813Srirajaskanthan 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.
Derived from this study: PubMed 32146619Dillon 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.
Derived from this study: PubMed 29330194Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Horsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pablo Lapuerta, MD study director

Lexicon Pharmaceuticals, Inc.

50 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telotristat etiprate in people with Carcinoid Syndrome, run by Lexicon Pharmaceuticals at 50 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany, United States, United Kingdom, France, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063659, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.