Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions

Journal of Gastroenterology and Hepatology
Yunsheng YangSam Lim

Abstract

Linaclotide is a guanylate cyclase-C agonist approved in multiple countries to treat irritable bowel syndrome with constipation (IBS-C). China has unmet need for well-tolerated therapy that is effective in treating both bowel and abdominal symptoms of IBS-C. This trial evaluated linaclotide's efficacy and safety in IBS-C patients in China and other regions. This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania. Patients reported bowel and abdominal symptoms daily; adverse events were monitored. Co-primary and secondary endpoints were tested using a predefined three-step serial gatekeeping multiple comparisons procedure. The intent-to-treat population included 839 patients (mean age = 41 years; 82% female; 81% Asian). The trial met all co-primary and secondary endpoints. Co-primary responder criteria were met by 60.0% of linaclotide patients versus 48.8% of placebo patients for abdominal pain/discomfort (≥ 30% decrease for ≥ 6/12 weeks; P < 0.05), and 31.7% of linaclotide versus 15.4% of placebo patients for IBS degree of relief (score ≤ 2 for ≥ 6/12 weeks; P < 0.0001). Secondary 12-week change-from-baseline endpoints (spontaneo...Continue Reading

References

Nov 28, 2002·Gastroenterology·Douglas A DrossmanWilliam E Whitehead
Mar 19, 2003·Alimentary Pharmacology & Therapeutics·A P S HunginF Mearin
Jun 4, 2005·Alimentary Pharmacology & Therapeutics·A P S HunginV Barghout
May 9, 2006·Gastroenterology·Douglas A Drossman
May 9, 2006·Gastroenterology·George F LongstrethRobin C Spiller
Jul 18, 2006·Alimentary Pharmacology & Therapeutics·J TackG Fisher
Apr 19, 2008·The New England Journal of Medicine·Emeran A Mayer
Aug 27, 2009·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·H EutameneL Bueno
Nov 26, 2010·Journal of Neurogastroenterology and Motility·Full-Young ChangTseng-Shing Chen
Mar 20, 2012·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Rebecca M Lovell, Alexander C Ford
Jun 29, 2017·The New England Journal of Medicine·Alexander C FordNicholas J Talley

❮ Previous
Next ❯

Citations

Oct 26, 2018·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·Shin FukudoToshifumi Ohkusa
Oct 26, 2018·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·Adam D FarmerAnthony R Hobson
Jul 23, 2019·Journal of Neurogastroenterology and Motility·Kok Ann GweeMichio Hongo
Dec 11, 2019·Minerva gastroenterologica e dietologica·Imke MasuyJan Tack
Feb 2, 2021·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Tomoyuki IshigoMasahide Fukudo
Mar 16, 2021·Drugs·Malte Lenders, Eva Brand
Mar 26, 2021·The Lancet. Gastroenterology & Hepatology·Michelle BosmanDaniel Keszthelyi
Apr 29, 2021·Alimentary Pharmacology & Therapeutics·Amol SharmaScott A Waldman
Jun 3, 2021·Chinese Medical Journal·Yi-Lin Liu, Jin-Song Liu
Jul 27, 2021·Gastroenterology Clinics of North America·Joy J Liu, Darren M Brenner
Aug 24, 2021·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Brigida BarberioAlexander C Ford
Sep 15, 2021·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·Vikram RanganAnthony Lembo

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.