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

November 1, 2021 updated by: Ironwood Pharmaceuticals, Inc.

A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Manchester
      • Wythenshawe, Manchester, United Kingdom
        • Peter Whorwell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 290 μg linaclotide
Linaclotide Oral, once daily
Drug: Linaclotide
Oral, once daily
Placebo Comparator: Matching Placebo
Matching Placebo Oral, once daily
Drug: Placebo
Oral, one daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Abdominal Girth at Week 4
Time Frame: Baseline, Week 4
Mean change in abdominal girth (physical measure of bloating/distension) as measured by area under the curve (AUC), determined by 24-hour abdominal inductance plesthymography (AIP; with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters [cm]).
Baseline, Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Abdominal Girth at Week 2
Time Frame: Baseline, Week 2
Mean change in abdominal girth (physical measure of bloating/distention) as measured by AUC, determined by 24-hour AIP (with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters [cm]).
Baseline, Week 2
Percent Change From Baseline in Maximal Abdominal Girth at Week 4
Time Frame: Baseline, Week 4
The maximum change in girth from the first hour, over the period from the 2nd hour to bedtime. The percentage change in maximum distension from baseline to 4 weeks will also be calculated.
Baseline, Week 4
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1
Time Frame: Baseline, Week 1
Symptom severity was assessed daily on an 11-point numerical rating scale (NRS) from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Baseline, Week 1
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2
Time Frame: Baseline, Week 2
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Baseline, Week 2
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3
Time Frame: Baseline, Week 3
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Baseline, Week 3
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4
Time Frame: Baseline, Week 4
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Baseline, Week 4
Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2
Time Frame: Baseline, Week 2
A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension symptoms on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain 'weekly' scores.
Baseline, Week 2
Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4
Time Frame: Baseline, Week 4
A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain 'weekly' scores.
Baseline, Week 4
Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time
Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4
Daily stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid). Daily average recorded BSFS scores for each participant were computed for each week.
Baseline, Week 1, Week 2, Week 3, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ironwood Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Manchester University NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Whorwell, University Hospital of South Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCP-103-403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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