Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

What Was Tested

This registered phase 2 trial tested Octreotide.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo Core Phase (experimental).

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females, aged 18 and older. Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging. Ability to provide written informed consent.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: surgery within 60 days prior to screening; A history of short bowel syndrome; life expectancy \<12 months.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2009-03 with completion listed for 2014-06.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase (time frame: Up to 4 Weeks Core Phase). Number of Participants With Any TEAE in the Open-Label Extension Phase (time frame: Up to 180 weeks in the open-label extension phase).

It also tracked 11 secondary outcomes, for example Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day, Change From Baseline in Weekly Mean Stool Form, Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate, Change From Baseline in Number of Cutaneous Flushing Episodes, Change From Baseline in Severity of Abdominal Pain or Discomfort and Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.