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

• Status: Terminated
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Collaborators: Manchester University NHS Foundation Trust; University Hospital of South Manchester NHS Foundation Trust
• Treatments: Linaclotide

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