Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome With Constipation

Treatments: Drug: Linaclotide or Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938717

MCP-103-302

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Enrollment: 805 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
• Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
• Patient meets protocol criteria for diagnosis of IBS-C
• Patient demonstrates continued IBS-C through Pretreatment Period
• Patient is compliant with IVRS

Exclusion criteria

• Patient has history of loose or watery stools
• Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
• Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
• 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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805 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Linaclotide or Matching Placebo

290 μg Linaclotide

Experimental group

Treatment:

Drug: Linaclotide or Matching Placebo