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Completed

NCT Number: NCT03223428

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

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).

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Key information

Conditions

Carcinoid Syndrome Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Serotonin Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RTI-HS

Research Triangle Park, North Carolina, 27709, United States

About this study

This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xermelo

Drug

This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.

Other names: Telotristat ethyl

Primary outcomes

  1. Percentage of Patients Who Are Satisfied With Their Overall Symptom Control

    Time frame: Baseline to 6 months

    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

  1. Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control

    Time frame: Baseline to 6 months

    Estimate percentage of patients reporting satisfaction with CS-related diarrhea control from Baseline to 6 months after starting Xermelo. At baseline participants were asked, "Currently, how satisfied are you with how your diarrhea is controlled?" At the 6-month follow-up survey, participants were asked, "Currently, how satisfied are you with how Xermelo has controlled your diarrhea?"

  2. Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control

    Time frame: Baseline to 6 months

    Estimate percentage of patients reporting satisfaction with CS-related flushing control from Baseline to 6 Months. At baseline, participants who had reported flushing as a symptom were asked, "Currently, how satisfied are you with how your flushing is controlled?" At 6 months, participants who had reported flushing as a symptom at Baseline were asked, "Currently, how satisfied are you with how Xermelo has controlled your flushing?"

  3. Number of Patients Reporting Reduction in Rescue SSA Use

    Time frame: Baseline to 6 months

    Number of participants reporting a reduction in rescue SSA use at 6 months after initiating treatment with Xermelo.

  4. Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection

    Time frame: Baseline to 6 months

    Percentage of patients reporting a reduction in the dose of long-acting SSA injection 6 months after patients initiated treatment with Xermelo

  5. Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection

    Time frame: Baseline to 6 months

    Estimate Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection 6 months after patients initiated treatment with Xermelo

  6. Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC)

    Time frame: Baseline to 6 months

    Estimate percentage of patients reporting an overall improvement in CS symptom control (diarrhea, flushing, frequency of BMs) after initiating Xermelo based on Patient Global Impression of Change (PGIC)

  7. Percentage Change of Patients Who Had Reduction in Work-related Absenteeism, Presenteeism, Activity Impairment, and Overall Productivity Loss From Baseline to 6 Months After Initiating Telotristat Ethyl Based on WPAI-SHP

    Time frame: Baseline to 6 months

    Estimate of the percentage of patients who had reduction in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss based on Worker Productivity and Activity Impairment: Specific Health Problem v2.0 (WPAI- SHP). The percentage change was measured from baseline to 6 months after treatment with telotristat ethyl.

  8. Percentage of Patients Reporting Weight Gain

    Time frame: Baseline to 6 months

    Estimate of the percentage of patients reporting weight gain after initiating Xermelo therapy.

Sponsors and collaborators

Lead sponsor

TerSera Therapeutics LLC

Industry

Registry information

Official study title

An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)

Acronym: RELAX

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2017
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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