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A Study of the Effect of Linaclotide on Abdominal Girth in Participants With IBS-C

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ClinicalTrials.gov Identifier: NCT02837783
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:
The objective of this trial is to determine the effect of linaclotide on abdominal girth in irritable bowel syndrome with constipation (IBS-C) participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Drug: Linaclotide Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mean Change in Abdominal Girth (physical measure of bloating/distention) [ Time Frame: Randomisation (Visit 4) to End of Treatment (Day 28±2) ]
    Mean change in abdominal girth (as measured by AUC) determined by 24-hour abdominal inductance plethysmography (AIP) between the linaclotide and placebo groups.


Secondary Outcome Measures :
  1. Change from Baseline in Abdominal Distension at Week 2 [ Time Frame: Baseline to Week 2 ]
    Mean change in abdominal girth (as measured by AUC) determined by 24-hour AIP, between the linaclotide and placebo groups.

  2. Change from Baseline in Maximal Abdominal Distension at Week 4 [ Time Frame: Baseline to 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.

  3. Change from Baseline of symptom severity (abdominal pain, discomfort, bloating, and distension) [ Time Frame: Baseline to End of Treatment (Day 28±2) ]
    Daily diary scores for each of the digestive symptoms and a composite score of these parameters will be averaged to obtain 'weekly' scores.

  4. Change from Baseline in Digestive sensations (subjective bloating, abdominal discomfort, abdominal distension and abdominal pain) at Weeks 4 and 8 [ Time Frame: Baseline to Week 4, Baseline to Week 8 ]
    The mean change in each of the hourly measures of digestive sensations (as measured by AUC), between the linaclotide and placebo groups.

  5. Change from Baseline of Bristol Stool Form Scale at Weeks 4 and 8 [ Time Frame: Baseline to Week 4, Baseline to Week 8 ]

    Daily diary BSFS scores will be recoded to represent discrepancies from a 'normal' stool type 4, daily average recoded BSFS scores for each subject will be computed. The following means will be calculated for each subject:

    • Baseline = mean (day -7 to day -1)
    • Week 1 = mean (day 1 to day 7)
    • Week 2 = mean (day 8 to day 14)
    • Week 3 = mean (day 15 to day 21)
    • Week 4 = mean (day 22 to day 28)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837783


Contacts
Contact: Ironwood Pharmaceuticals +1 (617) 621-8394

Locations
United Kingdom
Peter Whorwell Recruiting
Wythenshawe, Manchester, United Kingdom
Contact: Study Coordinator    +44 0161 291 5813      
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Manchester University NHS Foundation Trust
Investigators
Principal Investigator: Peter Whorwell University Hospital of South Manchester

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02837783     History of Changes
Other Study ID Numbers: MCP-103-403
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases