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Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

NCT02291679 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1223

Last updated 2017-06-15

Study results available
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Summary

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Linaclotide

DRUG

Matching Placebo

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard J Lavins, MD · Ironwood Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

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 NCT02291679 on ClinicalTrials.gov