NCT03223428

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™)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 223 (actual)
• Sponsor: TerSera Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Carcinoid Syndrome

Interventions

Type	Name	Description
DRUG	Xermelo	This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.

Timeline

• Start date: 2017-06-22
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2017-07-21
• Last updated: 2024-07-24
• Results posted: 2024-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study