Trial · NCT01677910
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
NCT01677910, Phase 3, Completed, Lexicon Pharmaceuticals; results first posted 2017-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome). Trials, record NCT01677910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01677910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
- NCT number
- NCT01677910
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 135 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Carcinoid Syndrome
- Interventions
- Telotristat etiprate, Placebo-matching telotristat etiprate
- First posted
- 2012-09-03
- Last updated
- 2018-02-27
- Other registries' IDs
- eudract:2012-003460-47
- Results first posted
- 2017-09-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks | Baseline and 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. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period | 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) | 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 | Number of Participants With TEAEs in the Open-Label Extension Period | 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) | 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. |
| Secondary | Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points | Baseline and 12 Weeks | 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. |
| Secondary | Change From Baseline in Abdominal Pain Averaged Across All Time-Points | Baseline and 12 Weeks | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks | Baseline and 12 Weeks | Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses. | counts/day | MEAN |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period | 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) | Safety population, defined as all subjects who received at least one dose of study drug was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels | Baseline and Week 12 | 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. | mg/24 hours | MEAN |
| SECONDARY | Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points | Baseline and 12 Weeks | Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses. | counts/day | MEAN |
| SECONDARY | Change From Baseline in Abdominal Pain Averaged Across All Time-Points | Baseline and 12 Weeks | Participants from the Intent-to-treat population, all randomized participants, with available data were included in the analyses. | units on a scale | MEAN |
| PRIMARY | Number of Participants With TEAEs in the Open-Label Extension Period | 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) | Safety population, defined as all subjects who received at least one dose of study drug was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks | Placebo | -0.623 | Standard Deviation 0.8275 | counts/day | |
| Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks | 250 mg Telotristat Etiprate | -1.433 | Standard Deviation 1.3652 | counts/day | |
| Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks | 500 mg Telotristat Etiprate | -1.455 | Standard Deviation 1.3098 | counts/day | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period | Placebo | 39 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period | 250 mg Telotristat Etiprate | 37 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period | 500 mg Telotristat Etiprate | 42 | Participants | ||
| Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels | Placebo | 11.350 | Standard Deviation 35.0346 | mg/24 hours | |
| Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels | 250 mg Telotristat Etiprate | -40.134 | Standard Deviation 84.7663 | mg/24 hours | |
| Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels | 500 mg Telotristat Etiprate | -57.519 | Standard Deviation 82.3273 | mg/24 hours | |
| Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points | Placebo | -0.164 | Standard Deviation 1.1572 | counts/day |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period | STARTED | Placebo | 45 | |
| Double-Blind Treatment Period | STARTED | 250 mg Telotristat Etiprate | 45 | |
| Double-Blind Treatment Period | STARTED | 500 mg Telotristat Etiprate | 45 | |
| Double-Blind Treatment Period | STARTED | Telotristat Etiprate Open-Label Extension | 0 | |
| Double-Blind Treatment Period | COMPLETED | Placebo | 38 | |
| Double-Blind Treatment Period | COMPLETED | 250 mg Telotristat Etiprate | 42 | |
| Double-Blind Treatment Period | COMPLETED | 500 mg Telotristat Etiprate | 38 | |
| Double-Blind Treatment Period | COMPLETED | Telotristat Etiprate Open-Label Extension | 0 | |
| Double-Blind Treatment Period | NOT COMPLETED | Placebo | 7 | |
| Double-Blind Treatment Period | NOT COMPLETED | 250 mg Telotristat Etiprate | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events468
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 45 | |
| other | Nausea | Gastrointestinal disorders | 250 mg Telotristat Etiprate | 6 | 45 | |
| other | Nausea | Gastrointestinal disorders | 500 mg Telotristat Etiprate | 14 | 45 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate Open-Label Extension | 27 | 115 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 8 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | 250 mg Telotristat Etiprate | 5 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | 500 mg Telotristat Etiprate | 10 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | Telotristat Etiprate Open-Label Extension | 35 | 115 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 45 | |
| other | Vomiting | Gastrointestinal disorders | 250 mg Telotristat Etiprate | 2 | 45 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 3 | 45 |
| Total, all-cause mortality | 250 mg Telotristat Etiprate | 1 | 45 |
| Total, all-cause mortality | 500 mg Telotristat Etiprate | 1 | 45 |
| Total, all-cause mortality | Telotristat Etiprate Open-Label Extension | 9 | 115 |
| Total, other adverse events | Placebo | 39 | 45 |
| Total, other adverse events | 250 mg Telotristat Etiprate | 37 | 45 |
| Total, other adverse events | 500 mg Telotristat Etiprate | 42 | 45 |
| Total, other adverse events | Telotristat Etiprate Open-Label Extension | 110 | 115 |
| Total, serious adverse events | Placebo | 7 | 45 |
| Total, serious adverse events | 250 mg Telotristat Etiprate | 7 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01677910
GET https://conductscience.org/api/trials/v1/NCT01677910/flow?page=2