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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: 290 μg linaclotide
Linaclotide Oral, once daily
Oral, once daily
Placebo Comparator: Matching Placebo
Matching Placebo Oral, once daily
Oral, one daily
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
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
|Contact: Ironwood Pharmaceuticals||+1 (617) 621-8394|
|Wythenshawe, Manchester, United Kingdom|
|Contact: Study Coordinator +44 0161 291 5813|
|Principal Investigator:||Peter Whorwell||University Hospital of South Manchester|