Trial · NCT04713202
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl
NCT04713202, Phase 2, Withdrawn, Chandrikha Chandrasekhara
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl. Trials, record NCT04713202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04713202
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl
- NCT number
- NCT04713202
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Chandrikha Chandrasekhara
- Conditions
- Neuroendocrine Tumors, Carcinoid Syndrome, Diarrhea
- Interventions
- Telotristat ethyl, Peptide Receptor Radionuclide Therapy, Placebo
- First posted
- 2021-01-19
- Last updated
- 2023-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | FACT-QS global QoL Score | From enrollment until completion of study therapy or subject withdrawal, up to six months | Feasibility of in-depth assessment of changes and improvement on treatment in patients undergoing treatment as determined by FACT-CS global QoL with PRRT using telotristat ethyl compared to placebo. The FACT-CS global QoL is the primary endpoint. Scores will be derived using FACIT guidelines and will range from 0 to 12 with higher scores denoting a better level of functioning. A repeated measures ANOVA will be applied and statistical significance of fixed effects of treatment arm, time and treatment arm by time interaction will be assessed using a Wilks' Lambda Approximate F test. |
| Secondary | To describe and report from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
| Secondary | ATo report changes in patient reported outcomes (PRO) in the diarrhea domain in patients undergoing PRRT receiving telotristat ethyl versus placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL Diarrhea domain as measured by the identified FACT-CS scales. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
| Secondary | To report changes in patient reported outcomes (PRO) in the flushing domain in patients undergoing PRRT receiving telotristat ethyl versus placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in QoL as measured by the identified FACT-CS scales in the flushing domain. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
| Secondary | To estimate the need of rescue short-acting somatostatin receptor antagonist in patients undergoing PRRT receiving telotristat ethyl versus placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency of rescue short acting somatostatin receptor antagonist use. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
| Secondary | To estimate the weight-gain in patients undergoing PRRT receiving telotristat ethyl versus placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in weight. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
| Secondary | To estimate the changes in bowel movement frequency and/or consistency in patients undergoing PRRT receiving telotristat ethyl versus placebo. | From enrollment until completion of study therapy or subject withdrawal, up to six months | Linear mixed effects regression model will be utilized to describe longitudinal changes in frequency and/or changes in consistency of bowel movements. Fixed effects for treatment arm, time and treatment arm by time interaction along with a random effect to account for the longitudinally correlated nature of repeated questionnaire measurements will be included. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04713202
GET https://conductscience.org/api/trials/v1/NCT04713202/registered