Clinical trial · Observational
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)
NCT03223428CI-TRIAL-00079106RELAXcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Xermelo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Carcinoid Syndrome patients initiating Xermelo
- description
- Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.
- interventionNames
- Drug: Xermelo
Primary outcomes (1)
- measure
- Percentage of Patients Who Are Satisfied With Their Overall Symptom Control
- timeFrame
- Baseline to 6 months
- description
- The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult, ≥18 years of age at the time of informed consent * A new, valid prescription for XERMELO * Initiating XERMELO for the treatment of carcinoid syndrome * Able and willing to provide informed consent prior to participation in the study Exclusion Criteria: * Unable to understand and read English * Unable to access the internet * Prior exposure to XERMELO
References
Publications (1)
- RESULTLi D, Darden C, Osman N, Sayeed S, Jackson L, Garbinsky D, Chauhan A. Real-World Clinical and Patient-Reported Outcomes from the Longitudinal Telotristat Ethyl Treatment Registry of Patients with Neuroendocrine Tumors. Cancer Manag Res. 2022 Oct 17;14:3009-3020. doi: 10.2147/CMAR.S386419. eCollection 2022. PMID 36262750