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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.303 | Other Identifier | Lexicon Pharmaceuticals, Inc. | |
| 2013-001543-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | Telotristat etiprate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Lapuerta, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Stanford | California | 94305 | 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. | |
| 32146619 |
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Participants with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were randomly assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind treatment period and were eligible to receive 500 mg telotristat etiprate in the open-label extension period.
Participants took part in the study at 31 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Netherlands, Spain, Sweden, United Kingdom, and the United States from 11 Mar 2014 to 29 Mar 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. |
| FG001 | 250 mg Telotristat Etiprate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
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| Placebo | Drug | Placebo-matching telotristat etiprate tablets |
|
| 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. |
| 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. | 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 |
| 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. | 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. | Baseline and 12 Weeks |
| 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 |
| Lexicon Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Lexicon Investigational Site | Kogara | New South Wales | 2217 | Australia |
| Lexicon Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Lexicon Investigational Site | Herston | Queensland | 4029 | Australia |
| Lexicon Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Lexicon Investigational Site | Edegem | B-2650 | Belgium |
| Lexicon Investigational Site | Ghent | 9000 | Belgium |
| Lexicon Investigational Site | Yvoir | 5530 | Belgium |
| Lexicon Investigational Site | Calgary | Alberta | T2N4N2 | Canada |
| Lexicon Investigational Site | Halifax | Nova Scotia | B0J1N0 | Canada |
| Lexicon Investigational Site | Clichy | 92118 | France |
| Lexicon Investigational Site | Lille | 59037 | France |
| Lexicon Investigational Site | Lyon | 69347 | 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 | 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 | Munich | 81377 | Germany |
| Lexicon Investigational Site | Neuss | 41464 | Germany |
| Lexicon Investigational Site | Jerusalem | 91120 | Israel |
| Lexicon Investigational Site | Amsterdam | North Holland | 1066X | Netherlands |
| Lexicon Investigational Site | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Lexicon Investigational Site | Noord Brahant | 5631BM | Netherlands |
| Lexicon Investigative Site | Rotterdam | 3015 CE | 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 | Uppsala | 75185 | Sweden |
| Lexicon Investigational Site | Basingstoke Hampshire | RG249NA | United Kingdom |
| Lexicon Investigational Site | Coventry | CV22DX | United Kingdom |
| Lexicon Investigational Site | London | NW3 2QG | 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 |
| 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. |
| 29330194 | Derived | 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. |
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. |
| FG002 | 500 mg Telotristat Etiprate | 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. |
| 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 included all participants who received at least one dose of study drug,
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. |
| BG001 | 250 mg Telotristat Etiprate | 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. |
| BG002 | 500 mg Telotristat Etiprate | 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. |
| 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) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 (5-HIAA) at Randomization | ULN=upper limit of normal. | Count of Participants | Participants |
| |||||||||||||||
| Region | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Baseline Body Mass Index (BMI) | BMI was calculated by weight (kg) / (height [cm] × 0.01)^2. | 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 | 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 participants 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 17.1 Weeks) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis. | Posted | Mean | Standard Deviation | percentage change of mg/24 hours | Baseline and 12 Weeks |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | Safety population, defined as all participants 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 52.6 Weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 for this endpoint were included in the analysis. | Posted | Mean | Standard Deviation | counts/day | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 Weeks |
| |||||||||||||||||||||||||||||||||
| 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 for this endpoint were included in the analysis. | 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 data available for this endpoint were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 Weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis. | Posted | Mean | Standard Deviation | counts/day | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.The Placebo arm is not included because all participants in the Placebo arm were receiving SSA therapy at Baseline. | Posted | Mean | Standard Deviation | counts/day | Baseline and 12 Weeks |
|
First dose of study drug to within 30 days of last dose of study drug (Up to 77.7 Weeks)
Data for the double-blind treatment period and the open-label extension period were analyzed separately. In the Non-Serious Adverse Event section, a result of "0" for a preferred term means that there are no participants in that arm above the 5% threshold.
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, 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. | 0 | 26 | 5 | 26 | 21 | 26 |
| EG001 | 250 mg Telotristat Etiprate | 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. | 0 | 25 | 1 | 25 | 25 | 25 |
| EG002 | 500 mg Telotristat Etiprate | 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. | 0 | 25 | 3 | 25 | 22 | 25 |
| 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. | 0 | 67 | 17 | 67 | 61 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urethral stent insertion | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Diagnostic procedure | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal resection | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Antibiotic prophylaxis | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Therapeutic embolisation | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | 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 |
| |
| 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 |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Influenzae | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | 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 |
| |
| Nasopharyngitis | Infections and infestations | 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
| Withdrawal of Consent |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Reason not Specified |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Sweden |
|
| Netherlands |
|
| Belgium |
|
| United States |
|
| United Kingdom |
|
| Israel |
|
| Australia |
|
| France |
|
| Germany |
|
| Spain |
|
| 4-Week |
|
| Not on SSA |
|
| Lanreotide |
|
| Unknown |
|
| Not Applicable |
|
| No |
|
| Not Applicable |
|
| > ULN |
|
| Unknown |
|
| Europe |
|
| Rest of the World |
|
|
|
|
|
|
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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.
|
|
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.
|
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