Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

NCT00813098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2010-12-02

Study results available
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Summary

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

LX1031 High Dose

A high dose of LX1031; daily oral intake for 28 days

DRUG

LX1031 Low Dose

A low dose of LX1031; daily oral intake for 28 days.

DRUG

Placebo

Matching placebo dosing with daily oral intake

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joel P. Freiman, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-07-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813098 on ClinicalTrials.gov