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COMPLETED Phase 2

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

NCT01456052 · View on ClinicalTrials.gov ↗

Study Summary

This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Telotristat Etiprate

Study Locations (20)

Other

  • Lexicon Investigational Site — Kaunas
  • Lexicon Investigational Site — Klaipėda
  • Lexicon Investigational Site — Šiauliai
  • Lexicon Investigational Site — Vilnius
  • Lexicon Investigational Site — Vilnius
  • Lexicon Investigational Site — Krakow
  • Lexicon Investigational Site — Lodz
  • Lexicon Investigational Site — Sopot
  • Lexicon Investigational Site — Warsaw

California

  • Lexicon Investigational Site — Anaheim
  • Lexicon Investigational Site — Santa Monica

New York

  • Lexicon Investigational Site — Great Neck
  • Lexicon Investigational Site — New York

Texas

  • Lexicon Investigational Site — Houston
  • Lexicon Investigational Site — San Antonio

Utah

  • Lexicon Investigational Site — Ogden
  • Lexicon Investigational Site — Sandy City

Arkansas

  • Lexicon Investigational Site — Little Rock

Oklahoma

  • Lexicon Investigational Site — Tulsa

Washington

  • Lexicon Investigational Site — Seattle

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2012-01-30
Est. Completion 2013-09-03
Phase Phase 2

Sponsor

Lexicon Pharmaceuticals

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01456052

The ClinicalTrials.gov registry entry for NCT01456052 describes a study currently listed as completed. It is categorized as Phase 2, 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 59 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 Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT01456052 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, New York. 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 NCT01456052 about?

NCT01456052 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis". This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

What is the current status of trial NCT01456052?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-01-30. Estimated completion is 2013-09-03.

What conditions does trial NCT01456052 study?

This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01456052?

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

Who is sponsoring clinical trial NCT01456052?

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 NCT01456052 being conducted?

This trial has 20 study locations across Arkansas, California, New York, Oklahoma, Texas. 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