Trial · NCT00853047
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day | 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. | injections per day | MEAN |
| SECONDARY | Time to First Rescue, Short-acting Octreotide | 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, As per protocol only the Placebo Core Phase and Telotristat Etiprate 500 mg Core Phase were included in the analysis. | days | MEDIAN |
| SECONDARY | Number of Participants Experiencing Complete Response at Week 4 | Baseline to Week 4 | The mITT Set Core Phase included 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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