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A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT ID: NCT02837783

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2018-10-31

Brief Summary

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The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.

Detailed Description

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Conditions

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Irritable Bowel Syndrome Characterized by Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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290 μg linaclotide

Linaclotide Oral, once daily

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

Matching Placebo

Matching Placebo Oral, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, one daily

Interventions

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Linaclotide

Oral, once daily

Intervention Type DRUG

Placebo

Oral, one daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth

Exclusion Criteria

* Patient has history of loose or watery stools
* Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Whorwell

Role: PRINCIPAL_INVESTIGATOR

University Hospital of South Manchester

Locations

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Peter Whorwell

Wythenshawe, Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MCP-103-403

Identifier Type: -

Identifier Source: org_study_id