Date: 2014-11-04
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Ironwood Pharmaceuticals (USA - MA)
Product: linaclotide
Action
mechanism:
- peptide. Linaclotide is a guanylate cyclase C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Ironwood and Actavis in the United States as Linzess® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is marketed by Almirall, S.A. for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma Inc. for development and commercialization of linaclotide in Japan and with AstraZeneca for development and commercialization in China.
Disease: chronic idiopathic constipation
Therapeutic
area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases
Country: USA
Trial
details:
Latest
news:
- • On November 4, 2014, Ironwood Pharmaceuticals announced the initiation of a Phase III clinical trial in the U.S. evaluating a 72 mcg capsule of linaclotide to be taken once per day for the treatment of adults suffering from chronic idiopathic constipation (CIC). Linaclotide is currently approved by the FDA as a 145 mcg capsule to be taken once per day for the treatment of adults with CIC and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Data from the Phase III trial of 72 mcg linaclotide are expected in 2016. The clinical trial is being conducted jointly by Ironwood and Actavis plc, Ironwood\'s co-development and co-promotion partner for linaclotide in the United States.
The randomized, double-blind, placebo-controlled, multi-site Phase III clinical trial is expected to enroll approximately 1,200 adult patients with CIC. Patients with CIC have fewer than three spontaneous bowel movements per week, and they also may experience recurrent straining, lumpy or hard stools, and/or a sensation that their bowels are not fully empty. Patients will be randomized to receive 145 mcg of linaclotide once per day, 72 mcg of linaclotide once per day, or placebo once per day for 12 weeks. The primary objective of the trial is to determine the efficacy and safety of linaclotide 72 mcg in adult patients with CIC. The primary efficacy assessment is the percentage of patients who experience at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline in the same week, and achieve both of these measures for nine out of 12 weeks (12-week CSBM Overall Responder).
Is
general: Yes
