Clinical trial NCT02837783: A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2016-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Abdominal Girth at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in Abdominal Girth at Week 2
timeFrame: Baseline, Week 2
measure: Percent Change From Baseline in Maximal Abdominal Girth at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1
timeFrame: Baseline, Week 1
measure: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
Other outcomes:
Locations:
city: Wythenshawe
country: United Kingdom
facility: Peter Whorwell
state: Manchester
Study officials:
affiliation: University Hospital of South Manchester
name: Peter Whorwell
role: PRINCIPAL_INVESTIGATOR
References: