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Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

NCT01642914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2016-04-26

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Conditions

Interventions

DRUG

Linaclotide 290 micrograms

oral capsule, taken once daily each morning at least 30 minutes before breakfast

DRUG

Linaclotide 145 micrograms

oral capsule, taken once daily each morning at least 30 minutes before breakfast

DRUG

Matching placebo

oral capsule, taken once daily each morning at least 30 minutes before breakfast

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Steven Shiff, MD · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-05-31
Completion
2013-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01642914 on ClinicalTrials.gov