Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO (RELAX)

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

Study Overview

• Status: Completed
• Conditions: Carcinoid Syndrome
• Intervention / Treatment: Drug: Xermelo

• Study Type: Observational
• Enrollment (Actual): 349

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • RTI-HS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include patients with CS and who are initiating treatment with XERMELO.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carcinoid Syndrome patients initiating Xermelo; Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.	Drug: Xermelo; This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.; Other Names: Telotristat ethyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who are satisfied with their overall symptom control	The proportion of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reporting satisfaction of CS-related diarrhea control	Estimate proportion of patients reporting satisfaction with CS-related diarrhea control	6 months
Proportion of patients reporting satisfaction of CS- related flushing control	Estimate proportion of patients reporting satisfaction with CS-related flushing control	6 months
Proportion of patients reporting reduction in rescue somatostatin analog (SSA) use	Estimate proportion of patients reporting reduction in rescue SSA use	6 months
Proportion of patients reporting reduction in the dose of long-acting SSA injection	Estimate proportion of patients reporting reduction in the dose of long-acting SSA injection	6 months
Proportion of patients reporting reduction in the frequency of long-acting SSA injection	Estimate proportion of patients reporting reduction in frequency of long-acting SSA injection	6 months
Proportion of patients reporting an overall improvement in CS control after initiating XERMELO based on patient global impression of change (PGIC)	Estimate proportion of patients reporting an overall improvement in CS control after initiating Xermelo based on PGIC	6 months
Proportion of patients that had reduction in 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)	Estimate the proportion of patients that had reduction in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss after initiating telotristat ethyl based on WPAI-SHP	6 months
Proportion of patients reporting weight gain	Estimate the proportion of patients reporting weight gain	6 months

Collaborators and Investigators

• Sponsor: TerSera Therapeutics LLC
• Investigators: Study Director: Lonnie Brent, PhD, TerSera Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Drug-Related Side Effects and Adverse Reactions; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
• Other Study ID Numbers: LX1606.1-401-CS; LX1606.401 (Other Identifier: TerSera Therapeutics)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes