Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Key facts

Study ID: NCT02291679
Run by: Ironwood Pharmaceuticals, Inc.
People needed: 1223
Starts: 2014-10-01
Expected to finish: 2015-08-01
Last updated by the study team: 2017-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

You may not qualify if…

Patient has 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 could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.

Where it is running

Ironwood Investigational Site — Phoenix, Arizona, United States
Ironwood Investigational Site — Tucson, Arizona, United States
Ironwood Investigational Site — North Little Rock, Arkansas, United States
Ironwood Investigational Site — Anaheim, California, United States
Ironwood Investigational Site — Chula Vista, California, United States
Ironwood Investigational Site — Garden Grove, California, United States
Ironwood Investigational Site — La Mesa, California, United States
Ironwood Investigational Site — North Hollywood, California, United States
Ironwood Investigational Site — Orange, California, United States
Ironwood Investigational Site — San Diego, California, United States
Ironwood Investigational Site — Thousand Oaks, California, United States
Ironwood Investigational Site — Colorado Springs, Colorado, United States
Ironwood Investigational Site — Bristol, Connecticut, United States
Ironwood Investigational Site — Boynton Beach, Florida, United States
Ironwood Investigational Site — Coral Gables, Florida, United States
Ironwood Investigational Site — DeLand, Florida, United States
Ironwood Investigational Site — Hialeah, Florida, United States
Ironwood Investigational Site — Inverness, Florida, United States
Ironwood Investigational Site — Jupiter, Florida, United States
Ironwood Investigational Site — Kissimmee, Florida, United States
Ironwood Investigational Site — Lauderdale Lakes, Florida, United States
Ironwood Investigational Site — Miami, Florida, United States
Ironwood Investigational Site — Miami, Florida, United States
Ironwood Investigational Site — Miami, Florida, United States
Ironwood Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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