Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.301 | Other Identifier | Lexicon Pharmaceuticals, Inc. | |
| 2012-003460-47 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period. |
|
| Telotristat Etiprate Open-Label Extension | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | Telotristat etiprate tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Week 12 |
| Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points |
Not provided
Inclusion Criteria:
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
Currently receiving stable-dose somatostatin analog (SSA) therapy
Minimum dose of long-acting release (LAR) or depot SSA therapy
Ability and willingness to provide written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pablo Lapuerta, MD | Lexicon Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Mobile | Alabama | 36604 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34598813 | Derived | 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. | |
| 32157590 |
Not provided
Not provided
Patients with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind period and were eligible to receive 500 mg telotristat etiprate in the 36 week open-label extension. 136 randomized;1 patient twice.
Participants took part in the study at 48 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, and the United States from 08 January 2013 to 21 March 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
|
|
| Placebo-matching telotristat etiprate | Drug | Placebo-matching telotristat etiprate tablets. |
|
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. |
| 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. | Baseline and 12 Weeks |
| 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 |
| Lexicon Investigational Site | Boston | Massachusetts | 02114 | United States |
| Lexicon Investigational Site | Boston | Massachusetts | 02215 | United States |
| Lexicon Investigational Site | Omaha | Nebraska | 68114 | United States |
| Lexicon Investigational Site | Buffalo | New York | 14263 | United States |
| Lexicon Investigational Site | New York | New York | 10029 | United States |
| Lexicon Investigational Site | Durham | North Carolina | 27710 | United States |
| Lexicon Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Lexicon Investigational Site | Fort Worth | Texas | 76104 | United States |
| Lexicon Investigational Site | Houston | Texas | 77030 | United States |
| Lexicon Investigational Site | McAllen | Texas | 78503 | United States |
| Lexicon Investigational Site | Kogara | New South Wales | 2217 | Australia |
| Lexicon Investigational Site | Saint Leanoards | New South Wales | 2065 | Australia |
| Lexicon Investigational Site | Herston | Queensland | 4029 | Australia |
| Lexicon Investigational Site | Fitzroy | Victoria | 3065 | Australia |
| Lexicon Investigational Site | Freemantle | Western Australia | 6160 | Australia |
| Lexicon Investigational Site | Woodville South | 5011 | Australia |
| Lexicon Investigational Site | Edegem | B-2650 | Belgium |
| Lexicon Investigational Site | Ghent | 9000 | Belgium |
| Lexicon Investigational Site | Yvoir | B-5530 | Belgium |
| Lexicon Investigational Site | Calgary | Alberta | T2N 4N2 | Canada |
| Lexicon Investigational Site | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Lexicon Investigational Site | Clichy | 92118 | France |
| Lexicon Investigational Site | Lille | 59037 | France |
| Lexicon Investigational Site | Lyon | 69437 | France |
| Lexicon Investigational Site | Marseille | 13385 | France |
| Lexicon Investigational Site | Strasbourg | 67098 | France |
| Lexicon Investigational Site | Villejuif | 94805 | France |
| Lexicon Investigational Site | Bad Berka | 99437 | Germany |
| Lexicon Investigational Site | Berlin | 13353 | Germany |
| Lexicon Investigational Site | Essen | 45147 | Germany |
| Lexicon Investigational Site | Hamburg | 20246 | Germany |
| Lexicon Investigational Site | Heidelberg | 69120 | Germany |
| Lexicon Investigational Site | Lübeck | 23538 | Germany |
| Lexicon Investigational Site | Mainz | 55131 | Germany |
| Lexicon Investigational Site | Marburg | 35043 | Germany |
| Lexicon Investigational Site | München | 81377 | Germany |
| Lexicon Investigational Site | Neuss | 41464 | Germany |
| Lexicon Invetigational Site | Jerusalem | 91120 | Israel |
| Lexicon Investigational Site | Bologna | 40138 | Italy |
| Lexicon Investigational Site | Ferrara | 44124 | Italy |
| Lexicon Investigational Site | Milan | 20089 | Italy |
| Lexicon Investigational Site | Milan | 20141 | Italy |
| Lexicon Investigational Site | Modena | 41126 | Italy |
| Lexicon Investigational Site | Naples | 80100 | Italy |
| Lexicon Investigational Site | Orbassano | 10043 | Italy |
| Lexicon Investigational Site | Perugia | 06156 | Italy |
| Lexicon Investigational Site | Pisa | 56124 | Italy |
| Lexicon Investigational Site | Rome | 00189 | Italy |
| Lexicon Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Lexicon Investigational Site | Noord-Brahant | 5631BM | Netherlands |
| Lexicon Investigational Site | Noord-Holland | 1066CX | Netherlands |
| Lexicon Investigational Site | Zuid-Holland | 3015E | Netherlands |
| Lexicon Investigational Site | Barcelona | 08035 | Spain |
| Lexicon Investigational Site | Barcelona | 08907 | Spain |
| Lexicon Investigational Site | Madrid | 28034 | Spain |
| Lexicon Investigational Site | Madrid | 28040 | Spain |
| Lexicon Investigational Site | Seville | 41013 | Spain |
| Lexicon Investigational Site | Lund | 22185 | Sweden |
| Lexicon Investigational Site | Uppsala | 75185 | Sweden |
| Lexicon Investigational Site | Basingstoke-Hampshire | RG249NA | United Kingdom |
| Lexicon Investigational Site | Coventry | CV2 2DX | United Kingdom |
| Lexicon Investigational Site | Glasgow | G12OYN | United Kingdom |
| Lexicon Investigational Site | Headington-Oxford | OX37LJ | United Kingdom |
| Lexicon Investigational Site | London | NW32QG | United Kingdom |
| Lexicon Investigational Site | London | SE59RS | United Kingdom |
| Lexicon Investigational Site | London | W12 OHS | United Kingdom |
| Lexicon Investigational Site | Manchester | M204BX | United Kingdom |
| Lexicon Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Derived |
| 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. |
| 32146619 | Derived | 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. |
| 31655936 | Derived | Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Oberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y. |
| 30477789 | Derived | Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Horsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24. |
| 29724499 | Derived | Weickert MO, Kaltsas G, Horsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Oberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1. |
| 250 mg Telotristat Etiprate |
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. |
| FG002 | 500 mg Telotristat Etiprate | 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. |
| FG003 | Telotristat Etiprate Open-Label Extension | Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Period (OLE) |
|
|
Safety population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period. |
| BG001 | 250 mg Telotristat Etiprate | 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. |
| BG002 | 500 mg Telotristat Etiprate | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Ethnicity data was not provided for 1 participant in France. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Race information was not provided for 11 participants from France. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Somatostatin Analog (SSA) Therapy Schedule at Study Entry | Patients who were on a 2-week SSA therapy or receiving SSA therapy via a subcutaneous continuous infusion pump are included in the "4-week" category. | Count of Participants | Participants |
| ||||||||||
| SSA Therapy Name at Study Entry | Count of Participants | Participants |
| |||||||||||
| Childbearing Potential | Count of Participants | Participants |
| |||||||||||
| Urinary 5-hydroxyindoleacetic acid (u5-HIAA) at Randomization | ULN=upper limit of normal | Count of Participants | Participants |
| ||||||||||
| Region | North America includes USA and Canada; Europe includes Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom; Rest of the World includes Australia and Israel. | Count of Participants | Participants |
| ||||||||||
| Weight | Weight data was not available for all participants. | Mean | Standard Deviation | kilogram (kg) |
| |||||||||
| Height | Height data was not available for all participants. | Mean | Standard Deviation | centimeter (cm) |
| |||||||||
| Body Mass Index (BMI) | BMI was calculated by weight (kg) / (height (cm) *0.01)^2. | Not all participants had weight and height data available to calculate BMI. | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses. | Posted | Mean | Standard Deviation | counts/day | Baseline and 12 Weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety population, defined as all subjects who received at least one dose of study drug was used for analysis. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with u5-HIAA data available at Baseline and Week 12 were included in the analyses. | Posted | Mean | Standard Deviation | mg/24 hours | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses. | Posted | Mean | Standard Deviation | counts/day | Baseline and 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with available data were included in the analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety population, defined as all subjects who received at least one dose of study drug was used for analysis. | Posted | Count of Participants | Participants | 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) |
|
|
First dose of study drug to within 30 days of last dose of study drug (Up to 72.2 Weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period. | 3 | 45 | 7 | 45 | 39 | 45 |
| EG001 | 250 mg Telotristat Etiprate | 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. | 1 | 45 | 7 | 45 | 37 | 45 |
| EG002 | 500 mg Telotristat Etiprate | Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the double-blind treatment period. | 1 | 45 | 8 | 45 | 42 | 45 |
| EG003 | Telotristat Etiprate Open-Label Extension | Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks. | 9 | 115 | 37 | 115 | 110 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Desseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Carcinoid heart disease | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Carcinoid syndrome | Endocrine disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Investigation | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Pancreatic neuroendocrine tumor metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Radiotherapy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Chemotherapy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Gastrostomy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Nephrostomy tube placement | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Therapeutic embolisation | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Post embolisation syndrome | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Cholangiogram | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pyonephrosis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Gamma-glutamyl transferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Alanine amino transferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased interest | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Lapuerta, MD | Lexicon Pharmaceuticals, Inc. | plapuerta@lexpharma.com |
| ID | Term |
|---|---|
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592493 | telotristat |
Not provided
Not provided
Not provided
| Reason not Specified |
|
| Withdrawal of Consent |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Lost to Follow-up |
|
|
|
| ≥ 65 years |
|
|
|
|
|
|
| Sweden |
|
|
| Netherlands |
|
|
| Belgium |
|
|
| United States |
|
|
| United Kingdom |
|
|
| Italy |
|
|
| Israel |
|
|
| Australia |
|
|
| France |
|
|
| Germany |
|
|
| Spain |
|
|
|
|
|
|
|
|
|
|
Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization. |
| Wilcoxon rank sum |
| < 0.001 |
| Mean Difference (Net) |
| -0.833 |
| 2-Sided |
| 95 |
| -1.292 |
| -0.374 |
Mean difference is calculated as LX1606-Placebo |
| Superiority |
| OG002 | 500 mg Telotristat Etiprate | 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. |
|
|
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. |
|
|
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. |
|
|
| OG002 |
| 500 mg Telotristat Etiprate |
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. |
|
|
|