- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02837783
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
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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
-
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Manchester
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Wythenshawe, Manchester, United Kingdom
- Peter Whorwell
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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
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 |
Intervention / Treatment |
---|---|
Experimental: 290 μg linaclotide
Linaclotide Oral, once daily
|
Oral, once daily
|
Placebo Comparator: Matching Placebo
Matching Placebo Oral, once daily
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Oral, one daily
|
What is the study measuring?
Primary Outcome Measures
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
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.
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Baseline, Week 1, Week 2, Week 3, Week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
December 21, 2016
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 15, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Constipation
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Guanylyl Cyclase C Agonists
- Enzyme Activators
- Linaclotide
Other Study ID 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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Astellas Pharma IncCompleted
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Astellas Pharma IncCompletedIrritable Bowel Syndrome With Constipation (IBS-C)Japan
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Ironwood Pharmaceuticals, Inc.CompletedIrritable Bowel Syndrome With ConstipationUnited States, Canada