A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Treatments: Drug: Linaclotide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03573908

MCP-103-312

Details and patient eligibility

About

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Full description

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

Enrollment: 614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has no clinically significant findings on a physical examination and clinical laboratory tests

• Female patients of childbearing potential must agree to use one of the following methods of birth control:

  1. Hormonal contraception
  2. Double-barrier birth control
  3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

• Patient meets protocol criteria for diagnosis of IBS-C

• Patient demonstrates continued IBS-C symptoms through Pretreatment Period

• Patient maintains a minimum level of compliance with daily diary

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: Double Blind

---

614 participants in 2 patient groups, including a placebo group

Linaclotide 290 µg

Experimental group

Description:

Participants receive linaclotide 290 µg orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are rerandomized to receive either linaclotide 290 µg or placebo for 4 weeks in the Randomized Withdrawal Period.

Treatment:

Drug: Placebo

Drug: Linaclotide

Placebo

Placebo Comparator group

Description:

Participants receive placebo to linaclotide orally once daily for 12 weeks during the Treatment Period. At Week 12 participants are switched to receive linaclotide 290 µg for 4 weeks during the Randomized Withdrawal Period.

Treatment:

Drug: Placebo

Drug: Linaclotide