Trial · NCT00853047
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
NCT00853047, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2018-12-26
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 Not Managed by Stable-Dose Octreotide Therapy. Trials, record NCT00853047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853047
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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 Not Managed by Stable-Dose Octreotide Therapy
- NCT number
- NCT00853047
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Carcinoid Syndrome
- Interventions
- Telotristat etiprate, Octreotide LAR Depot, Placebo
- First posted
- 2009-02-27
- Last updated
- 2018-12-26
- Results first posted
- 2018-12-26
Source ClinicalTrials.gov
Registered outcomes13
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 Event (TEAE) and Any Drug-related TEAE in the Core Phase | Up to 4 Weeks 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. A TEAE was an AE reported after the first dose of randomized treatment on Day 1. |
| Primary | Number of Participants With Any TEAE in the Open-Label Extension Phase | Up to 180 weeks in the open-label extension phase | An 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 receiving treatment. |
| Secondary | Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day | Baseline to Week 4 | Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Weekly Mean Stool Form | Baseline to Week 4 | Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate | Baseline to Week 4 | Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Number of Cutaneous Flushing Episodes | Baseline to Week 4 | Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Severity of Abdominal Pain or Discomfort | Baseline to Week 4 | Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) | Baseline to Week 4 | u5-HIAA is a standard test used in clinical practice to assess the 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 Chromogranin A | Baseline to Week 4 | Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement. |
| Secondary | Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome | Week 4 | Participants were asked to answer 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 number of participants who answered Yes are reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Event (TEAE) and Any Drug-related TEAE in the Core Phase | Up to 4 Weeks Core Phase | The Safety Set Core Phase included all participants who received at least one dose of study drug in the core phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any TEAE in the Open-Label Extension Phase | Up to 180 weeks in the open-label extension phase | The Safety Set Extension Period included all participants who received at least one dose of study drug in the open-label extensions phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day | Baseline to Week 4 | Participants from the modified Intent to Treat (mITT) Set, Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. | bowel movements/day | MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Stool Form | Baseline to Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate | Baseline to Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug with data available for analysis. | percentage of days | MEAN |
| SECONDARY | Change From Baseline in Number of Cutaneous Flushing Episodes | Baseline to Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. | cutaneous flushing episodes | MEAN |
| SECONDARY | Change From Baseline in Severity of Abdominal Pain or Discomfort | Baseline to Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. Last Observation Carried Forward (LOCF) | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) | Baseline to Week 4 | Participants from the Pharmacodynamic (PD) Analysis Set Core Phase, all participants who received any fraction of a dose of study drug and had a valid Baseline and at least 1 valid post-Baseline PD assessment, with data available for analysis. | mg/24 hours | MEAN |
| SECONDARY | Change From Baseline in Chromogranin A | Baseline to Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. | ng/mL | MEAN |
| SECONDARY | Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome | Week 4 | Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group63
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 Event (TEAE) and Any Drug-related TEAE in the Core Phase | Placebo Core Phase | Any TEAE | 4 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 150 mg Core Phase | Any TEAE | 3 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 250 mg Core Phase | Any TEAE | 3 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 350 mg Core Phase | Any TEAE | 2 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 500 mg Core Phase | Any TEAE | 9 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Placebo Core Phase | Related TEAEs | 3 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 150 mg Core Phase | Related TEAEs | 3 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 250 mg Core Phase | Related TEAEs | 0 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 350 mg Core Phase | Related TEAEs | 2 | Participants | |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase | Telotristat Etiprate 500 mg Core Phase | Related TEAEs | 6 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase | STARTED | Placebo Core Phase | 5 | |
| Core Phase | STARTED | Telotristat Etiprate 150 mg Core Phase | 3 | |
| Core Phase | STARTED | Telotristat Etiprate 250 mg Core Phase | 3 | |
| Core Phase | STARTED | Telotristat Etiprate 350 mg Core Phase | 3 | |
| Core Phase | STARTED | Telotristat Etiprate 500 mg Core Phase | 9 | |
| Core Phase | STARTED | Telotristat Etiprate Open-Label Extension Phase | 0 | |
| Core Phase | COMPLETED | Placebo Core Phase | 5 | |
| Core Phase | COMPLETED | Telotristat Etiprate 150 mg Core Phase | 3 | |
| Core Phase | COMPLETED | Telotristat Etiprate 250 mg Core Phase | 3 | |
| Core Phase | COMPLETED | Telotristat Etiprate 350 mg Core Phase | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,170
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 | Diarrhoea | Gastrointestinal disorders | Placebo Core Phase | 2 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate 150 mg Core Phase | 0 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate 250 mg Core Phase | 2 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate 350 mg Core Phase | 0 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate 500 mg Core Phase | 4 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Telotristat Etiprate Open-Label Extension Phase | 10 | 19 | |
| other | Nausea | Gastrointestinal disorders | Placebo Core Phase | 1 | 5 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate 150 mg Core Phase | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate 250 mg Core Phase | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Telotristat Etiprate 350 mg Core Phase | 0 | 3 |
1 to 10 of 1,170Source ClinicalTrials.gov
See all 1,170 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Core Phase | 0 | 5 |
| Total, all-cause mortality | Telotristat Etiprate 150 mg Core Phase | 0 | 3 |
| Total, all-cause mortality | Telotristat Etiprate 250 mg Core Phase | 0 | 3 |
| Total, all-cause mortality | Telotristat Etiprate 350 mg Core Phase | 0 | 3 |
| Total, all-cause mortality | Telotristat Etiprate 500 mg Core Phase | 0 | 9 |
| Total, all-cause mortality | Telotristat Etiprate Open-Label Extension Phase | 1 | 19 |
| Total, other adverse events | Placebo Core Phase | 4 | 5 |
| Total, other adverse events | Telotristat Etiprate 150 mg Core Phase | 3 | 3 |
| Total, other adverse events | Telotristat Etiprate 250 mg Core Phase | 3 | 3 |
| Total, other adverse events | Telotristat Etiprate 350 mg Core Phase | 2 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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/NCT00853047
GET https://conductscience.org/api/trials/v1/NCT00853047/results?page=2