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NCT03223428 Clinical Trial

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

Carcinoid Syndrome Clinical Trial

— RELAX  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03223428
Other study ID # LX1606.1-401-CS
Secondary ID LX1606.401
Status Completed
Phase
First received
Last updated
Start date June 22, 2017
Est. completion date January 14, 2022

Study information
Verified date January 2022
Source TerSera Therapeutics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 349
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xermelo
This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.

Locations
Country Name City State
United States RTI-HS Research Triangle Park North Carolina

Sponsors (1)
Lead Sponsor Collaborator
TerSera Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Proportion of patients reporting satisfaction of CS-related diarrhea control Estimate proportion of patients reporting satisfaction with CS-related diarrhea control 6 months
Secondary Proportion of patients reporting satisfaction of CS- related flushing control Estimate proportion of patients reporting satisfaction with CS-related flushing control 6 months
Secondary Proportion of patients reporting reduction in rescue somatostatin analog (SSA) use Estimate proportion of patients reporting reduction in rescue SSA use 6 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Proportion of patients reporting weight gain Estimate the proportion of patients reporting weight gain 6 months
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