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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Constipation, Constipation

In brief

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.

Key facts

Study ID

NCT01642914

Run by

Forest Laboratories

People needed

487

Starts

2012-08-01

Expected to finish

2013-08-01

Last updated by the study team

2016-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Straining during more than 25% of BMs
• Lumpy or hard stools during more than 25% of BMs
• 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)

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 102 — Chandler, Arizona, United States
• Forest Investigative Site 149 — Glendale, Arizona, United States
• Forest Investigative Site 126 — Goodyear, Arizona, United States
• Forest Investigative Site 018 — Phoenix, Arizona, United States
• Forest Investigative Site 061 — Phoenix, Arizona, United States
• Forest Investigative Site 022 — Scottsdale, Arizona, United States
• Forest Investigative Site 079 — Tucson, Arizona, United States
• Forest Investigative Site 071 — Tucson, Arizona, United States
• Forest Investigative Site 135 — North Little Rock, Arkansas, United States
• Forest Investigative Site 106 — Anaheim, California, United States
• Forest Investigative Site 104 — Laguna Hills, California, United States
• Forest Investigative Site 066 — Mission Hills, California, United States
• Forest Investigative Site 095 — San Carlos, California, United States
• Forest Investigative Site 009 — San Diego, California, United States
• Forest Investigative Site 151 — Santa Monica, California, United States
• Forest Investigative Site 010 — Westlake Village, California, United States
• Forest Investigative Site 012 — Boulder, Colorado, United States
• Forest Investigative Site 041 — Colorado Springs, Colorado, United States
• Forest Investigative Site 045 — Colorado Springs, Colorado, United States
• Forest Investigative Site 060 — Longmont, Colorado, United States
• Forest Investigative Site 007 — Bristol, Connecticut, United States
• Forest Investigative Site 153 — Waterbury, Connecticut, United States
• Forest Investigative Site 091 — Boynton Beach, Florida, United States
• Forest Investigative Site 047 — Bradenton, Florida, United States
• Forest Investigative Site 020 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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