Trial · NCT01104415
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
NCT01104415, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2018-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome. Trials, record NCT01104415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01104415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
- NCT number
- NCT01104415
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Carcinoid Syndrome
- Interventions
- Telotristat etiprate
- First posted
- 2010-04-15
- Last updated
- 2019-03-15
- Other registries' IDs
- eudract:2009-016973-13
- Results first posted
- 2018-04-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase | Baseline up to Week 12 in the Core Phase | 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. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1. |
| Primary | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period | Up to 124 Weeks in the 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. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1. |
| Secondary | Change From Baseline in Number of Bowel Movements (BMs) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Participants recorded the number of bowel movements in a daily diary. The change from baseline value was calculated as the difference between mean numbers of BMs of the post-baseline interval (Weeks 9 to 12) and baseline. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Change From Baseline in Stool Form/Consistency | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Participants assessed stool form/consistency in a daily diary using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery). The change from the baseline value was calculated as the difference between a mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score and 5 indicates the worst score. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Participants assessed the urgency to defecate using a daily diary response to the following question, "Have you felt or experienced a sense of urgency to pass stool today?". The change from the baseline value was calculated as the difference between the mean score (percentage of days) of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Sensation/severity of nausea was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of nausea experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome | Core Phase: Weeks 9-12; Extension Period: Week 24 | Participants assessed their symptoms using a weekly subjective response to the following question, "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?". The values for improvement in global assessment of symptoms associated with carcinoid syndrome in the Core Phase were averaged from Weeks 9 to 12. |
| Secondary | Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | The severity of abdominal pain was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of abdominal pain or experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicate the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Change From Baseline in Daily Number of Cutaneous Flushing Episodes | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Participants recorded the number of daily cutaneous flushing episodes experienced in the daily diary. The change from baseline value was calculated as the difference between the mean numbers of cutaneous flushing episodes of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug. |
| Secondary | Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase | Baseline to Week 12 | Clinically meaningful symptom reduction was defined as either: a) an average of \< 4 bowel movements per day over 15 consecutive days, b) a 50% reduction from baseline in the number of bowel movements, c) a positive response to the question regarding adequate relief, or d) a 50% reduction from baseline in the number of daily flushing episodes. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase | Baseline up to Week 12 in the Core Phase | The safety set (SS) included all the enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period | Up to 124 Weeks in the Extension Period | SS included all enrolled participants who had received at least 1 dose of study drug in the 124-week Extension Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Number of Bowel Movements (BMs) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | Efficacy full analysis set (EFAS) in Core Phase included all participants with at least 1 post-Baseline efficacy assessment and full analysis set (FAS) in Extension Period(EP) included all participants in SS with at least 1 post-Baseline efficacy assessment in 124-week EP. Number analyzed is the participants with evaluable data at given time point. | number of bowel movements/day | MEAN |
| SECONDARY | Change From Baseline in Stool Form/Consistency | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | EFAS in the Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in the Extension period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in 124-week Extension Period. Number analyzed is the number of participants with evaluable data at given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point. | percentage of days | MEAN |
| SECONDARY | Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point. | score on a scale | MEAN |
| SECONDARY | Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome | Core Phase: Weeks 9-12; Extension Period: Week 24 | EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS) | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Number of Cutaneous Flushing Episodes | Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24 | EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point. | Daily number of flushing episodes | MEAN |
| SECONDARY | Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase | Baseline to Week 12 | EFAS included all participants who had at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase | Telotristat Etiprate- Core Phase | Any TEAE | 15 | Participants | |
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase | Telotristat Etiprate- Core Phase | Drug-Related TEAE | 5 | Participants | |
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period | Telotristat Etiprate- Extension Period | Any TEAE | 11 | Participants | |
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period | Telotristat Etiprate- Extension Period | Drug-Related TEAE | 4 | Participants | |
| Change From Baseline in Number of Bowel Movements (BMs) | Telotristat Etiprate- Core Phase | -2.60 | Standard Deviation 1.381 | number of bowel movements/day | |
| Change From Baseline in Number of Bowel Movements (BMs) | Telotristat Etiprate- Extension Period | -2.85 | Standard Deviation 1.64 | number of bowel movements/day | |
| Change From Baseline in Stool Form/Consistency | Telotristat Etiprate- Core Phase | -0.79 | Standard Deviation 0.707 | score on a scale | |
| Change From Baseline in Stool Form/Consistency | Telotristat Etiprate- Extension Period | -1.31 | Standard Deviation 0.666 | score on a scale | |
| Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate | Telotristat Etiprate- Core Phase | -11.32 | Standard Deviation 36.660 | percentage of days | |
| Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate | Telotristat Etiprate- Extension Period | -22.79 | Standard Deviation 49.546 | percentage of days |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase | STARTED | Telotristat Etiprate- Core Phase | 15 | |
| Core Phase | STARTED | Telotristat Etiprate -Extension Period | 0 | |
| Core Phase | COMPLETED | Telotristat Etiprate- Core Phase | 14 | |
| Core Phase | COMPLETED | Telotristat Etiprate -Extension Period | 0 | |
| Core Phase | NOT COMPLETED | Telotristat Etiprate- Core Phase | 1 | |
| Core Phase | NOT COMPLETED | Telotristat Etiprate -Extension Period | 0 | |
| Extension Period | STARTED | Telotristat Etiprate- Core Phase | 0 | |
| Extension Period | STARTED | Telotristat Etiprate -Extension Period | 11 | |
| Extension Period | COMPLETED | Telotristat Etiprate- Core Phase | 0 | |
| Extension Period | COMPLETED | Telotristat Etiprate -Extension Period | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events220
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 | Abdominal pain | Gastrointestinal disorders | Telotristat Etiprate- Core Phase | 6 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Telotristat Etiprate- Extension Period | 2 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate- Core Phase | 3 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate- Extension Period | 4 | 11 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Telotristat Etiprate- Core Phase | 2 | 15 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Telotristat Etiprate- Extension Period | 2 | 11 | |
| other | Flatulence | Gastrointestinal disorders | Telotristat Etiprate- Core Phase | 2 | 15 | |
| other | Flatulence | Gastrointestinal disorders | Telotristat Etiprate- Extension Period | 0 | 11 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate- Core Phase | 2 | 15 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate- Extension Period | 2 | 11 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telotristat Etiprate- Core Phase | 0 | 15 |
| Total, all-cause mortality | Telotristat Etiprate- Extension Period | 1 | 11 |
| Total, other adverse events | Telotristat Etiprate- Core Phase | 15 | 15 |
| Total, other adverse events | Telotristat Etiprate- Extension Period | 11 | 11 |
| Total, serious adverse events | Telotristat Etiprate- Core Phase | 3 | 15 |
| Total, serious adverse events | Telotristat Etiprate- Extension Period | 7 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25636046 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Telotristat Etiprate- Core Phase vs Telotristat Etiprate- Extension Period: Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome | Trial comparisons |
| Telotristat Etiprate- Core Phase vs Telotristat Etiprate- Extension Period: deaths from any cause | Trial comparisons |
| Telotristat Etiprate- Core Phase vs Telotristat Etiprate- Extension Period: serious adverse events | Trial comparisons |
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/NCT01104415
GET https://conductscience.org/api/trials/v1/NCT01104415/results?page=2