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NCT01456052 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Ulcerative Colitis, sponsored by Lexicon Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
59
Enrollment target
20
Study locations

NCT01456052 is a Phase 2 study of Ulcerative Colitis that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 59 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT01456052, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Lexicon Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
59 participants
Enrollment target
20
Study locations

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

Ulcerative Colitis

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

56 total trials

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What the Registry Record Tells You About NCT01456052

The ClinicalTrials.gov registry entry for NCT01456052 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.

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.

NCT01456052 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, New York.

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.

What interventions are being tested in trial NCT01456052?

The interventions under investigation include: Placebo (DRUG), Telotristat Etiprate (DRUG).

Who is sponsoring clinical trial NCT01456052?

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

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.

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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.