Media Articles Related to Amitiza (Lubiprostone)
Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Source: MedicineNet Irritable Bowel Syndrome Specialty [2013.05.09]
Title: Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Created: 5/9/2013 12:00:00 AM
Last Editorial Review: 5/9/2013 12:00:00 AM
Linzess (Linaclotide) For IBS With Constipation Or Chronic Idiopathic Constipation Now Available, USA
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.12.27]
Linzess (linaclotide), a medication for irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation is now available in American pharmacies, Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc announced.
Linaclotide Given Positive CHMP Opinion For Irritable Bowel Syndrome With Constipation
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.10.01]
Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) have announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing approval for Constella® (linaclotide 290 micrograms), for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Source: MedicineNet Anal Fissure Specialty [2012.09.19]
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/19/2012 12:00:00 AM
IBS-C And Chronic Idiopathic Constipation Treatment LINZESS (Linaclotide) Receives FDA Approval
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.09.06]
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced today that LINZESS™ (linaclotide) was approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Published Studies Related to Amitiza (Lubiprostone)
Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. [2011.06]
BACKGROUND: Lubiprostone is a prostone analog with a novel mechanism of action involving type-2 chloride channel activation. The aim of this work was to perform a dose-finding study for lubiprostone for the treatment of constipation with or without irritable bowel syndrome (IBS) in Japan... CONCLUSIONS & INFERENCES: Our results suggest that lubiprostone produced a steady and effective improvement in the symptoms of CIC with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population.
Efficacy and safety of lubiprostone in patients with chronic constipation. [2010.04]
AIMS: The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation... CONCLUSIONS: In patients with chronic constipation, lubiprostone produced a bowel movement in the majority of individuals within 24 h of initial dosing, with sustained improvement in frequency as well as other constipation symptoms over 4 weeks of treatment.
Lubiprostone neither decreases gastric and small-bowel transit time nor improves visualization of small bowel for capsule endoscopy: a double-blind, placebo-controlled study. [2009.11]
BACKGROUND: Lubiprostone, a selective activator of type 2 chloride channels, is approved for treatment of chronic idiopathic constipation and recently constipation-predominant irritable bowel syndrome. It has been suggested that lubiprostone has a prokinetic effect. OBJECTIVE: This investigation was designed to evaluate lubiprostone as a preparation and propulsive agent for small-bowel capsule endoscopy. The PillCam Small Bowel capsule endoscopy system with the PillCam SB1 capsule and Rapid 5 software platform were used. DESIGN: The study was designed as a double-blind, placebo-controlled trial. PATIENTS: Forty healthy adults. MAIN OUTCOME MEASURES: Gastric transit time (GTT), small-bowel transit time (SBTT), and adequacy of small-bowel cleansing preparation. INTERVENTIONS: The study subjects received 24 mug lubiprostone or placebo 30 minutes before PillCam capsule ingestion... CONCLUSION: Lubiprostone produced a significant increase in GTT but did not result in a significant decrease in SBTT compared with placebo. The administration of lubiprostone before capsule ingestion did not result in improved overall preparation of the small bowel for capsule endoscopy or increase the percentage of visualized small bowel. (The trial was registered at www.clinicaltrials.gov, identifier NCT00746395.).
Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. [2009.02.01]
BACKGROUND: Effective treatments for irritable bowel syndrome with constipation (IBS-C) are lacking. AIM: To assess the efficacy and safety of lubiprostone in IBS-C... CONCLUSIONS: The percentage of overall responders based on patient-rated assessments of IBS-C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.
Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. [2009.02]
Lubiprostone, a bicyclic fatty acid chloride channel activator, is efficacious in treatment of chronic constipation and constipation-predominant irritable bowel syndrome. The study aim was to compare effects of lubiprostone and placebo on colonic sensory and motor functions in humans...
Clinical Trials Related to Amitiza (Lubiprostone)
Amitiza in Constipation Associated With PD (Parkinson's Disease) [Recruiting]
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be
safe and effective for chronic constipation, will also improve constipation symptoms in
Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in
bowel movement consistency, quality of life and motor symptoms.
Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation [Recruiting]
The primary objective is to compare the effectiveness and tolerance of Amitiza®
(lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and
GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for
Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation [Not yet recruiting]
The purpose of this study is to determine if lubiprostone may change the rate of movement
of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)
tract is slower due to constipation.
To be able to measure the time difference in the duration of transit of the FDA approved
SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure
The investigators anticipate to capture the possibility to reduce/eliminate the small
intestinal bacterial overgrowth in chronically constipated patients after administration of
study drug- lubiprostone.
Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation [Not yet recruiting]
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or
discomfort in association with altered bowel habit. IBS is further subcategorized as three
types according to the predominant bowel movement pattern: IBS with constipation (IBS-C),
IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain
incompletely understood, but proposed mechanisms include abnormal motility, visceral
hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI
Lubiprostone, a novel drug that works by activating the colonic ClC-2 chloride channel, has
been approved for use in patients with chronic idiopathic constipation and recently approved
for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride
channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen
which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C
receiving lubiprostone have reported improvements in many symptoms such as abdominal pain
and constipation. However, there is limited physiologic data to explain how exactly
lubiprostone improves IBS-C symptoms.
The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal
pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown
to accurately measure whole gut as well as regional (i. e. stomach, small bowel, colon)
The primary aim of this study is to determine the effects of lubiprostone on whole GI tract
transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through
evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone
vs. placebo on these parameters, and secondarily to evaluate changes in these parameters
with differing doses of lubiprostone.
The investigators hypothesize that lubiprostone will increase whole GI and colonic transit
compared to placebo in patient with IBS. the investigators do not expect a change in
intraluminal pH with lubiprostone compared to placebo.
Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation [Recruiting]
The objective of this study is to evaluate the clinical equivalence and safety of the test
formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd
compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo
Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
Reports of Suspected Amitiza (Lubiprostone) Side Effects
Chest Discomfort (26),
Chest Pain (12),
Confusional State (6),
Drug Ineffective (6),
Constipation (6), more >>