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Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT00460811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2013-02-04

Study results available
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Summary

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Conditions

  • Irritable Bowel Syndrome With Constipation

Interventions

DRUG

Linaclotide Acetate

Oral, once daily

DRUG

Matching placebo

Oral, once daily

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Microbia Medical Director, MD · Microbia, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • United States
  • Canada

Study Locations

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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 NCT00460811 on ClinicalTrials.gov