A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Treatments: Drug: Linaclotide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02837783

MCP-103-403

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

290 μg linaclotide

Experimental group

Description:

Linaclotide Oral, once daily

Treatment:

Drug: Linaclotide

Matching Placebo

Placebo Comparator group

Description:

Matching Placebo Oral, once daily

Treatment:

Drug: Placebo