Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation; Constipation

Treatments: Drug: Matching placebo; Drug: Linaclotide 290 micrograms; Drug: Linaclotide 145 micrograms

Study type: Interventional

Funder types: Industry

Identifiers

NCT01642914

LIN-MD-04

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Enrollment: 487 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings

• Patient has successfully completed protocol procedures (with no clinically significant findings)

• Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:

  1. Straining during more than 25% of BMs
  2. Lumpy or hard stools during more than 25% of BMs
  3. Sensation of incomplete evacuation during more than 25% of BMs

• Patient demonstrates continued chronic constipation and bloating through Pretreatment Period

• Patient is compliant with Interactive voice response System (IVRS)

Exclusion criteria

• Patient has a history of loose or watery stools
• Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
• 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 would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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487 participants in 3 patient groups, including a placebo group

Linaclotide 290 micrograms

Experimental group

Description:

Linaclotide 290 micrograms

Treatment:

Drug: Linaclotide 290 micrograms

Linaclotide 145 Micrograms

Experimental group

Description:

Linaclotide 145 micrograms

Treatment:

Drug: Linaclotide 145 micrograms

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Matching placebo