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NCT01677910 · ClinicalTrials.gov registry record · Phase 3

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

A Phase 3 study of Carcinoid Syndrome, sponsored by Lexicon Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
135
Enrollment target
20
Study locations

NCT01677910 is a Phase 3 study of Carcinoid Syndrome that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 135 participants, above the 110-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT01677910, a Phase 3 study of Carcinoid Syndrome, has completed, sponsored by Lexicon Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
135 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Conditions Studied

Carcinoid Syndrome

Interventions

  • DRUG Telotristat etiprate
  • DRUG Placebo-matching telotristat etiprate

Study Locations (20)

Texas

  • Lexicon Investigational Site - Fort Worth
  • Lexicon Investigational Site - Houston
  • Lexicon Investigational Site - McAllen

California

  • Lexicon Investigational Site - Palo Alto
  • Lexicon Investigational Site - San Francisco

Massachusetts

  • Lexicon Investigational Site - Boston
  • Lexicon Investigational Site - Boston

New York

  • Lexicon Investigational Site - Buffalo
  • Lexicon Investigational Site - New York

New South Wales

  • Lexicon Investigational Site - Kogara
  • Lexicon Investigational Site - Saint Leanoards

Alabama

  • Lexicon Investigational Site - Mobile

Florida

  • Lexicon Investigational Site - Orlando

Iowa

  • Lexicon Investigational Site - Iowa City

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2013-01-08
Est. Completion 2016-03-21
Phase Phase 3

Sponsor

Lexicon Pharmaceuticals

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01677910

The ClinicalTrials.gov registry entry for NCT01677910 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (23% higher). The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoid Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Telotristat etiprate is the first listed.

NCT01677910 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01677910 about?

NCT01677910 is a clinical study titled "TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)". The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not a...

What is the current status of trial NCT01677910?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2013-01-08. Estimated completion is 2016-03-21.

What conditions does trial NCT01677910 study?

This clinical trial studies the following conditions: Carcinoid Syndrome.

What interventions are being tested in trial NCT01677910?

The interventions under investigation include: Telotristat etiprate (DRUG), Placebo-matching telotristat etiprate (DRUG).

Who is sponsoring clinical trial NCT01677910?

This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01677910 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.