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COMPLETED Phase 3

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

NCT01677910 · View on ClinicalTrials.gov ↗

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

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

12 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01677910 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01677910?

The interventions under investigation include: Telotristat etiprate (DRUG), Placebo-matching telotristat etiprate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01677910?

This trial is sponsored by Lexicon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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