Lubiprostone is a locally acting chloride channel activator that enhances a
chloride-rich intestinal fluid secretion without altering sodium and potassium
concentrations in the serum. Amitiza (lubiprostone) is chemically designated as (┬ľ)-7-[(2 R,4a R,5 R,7a R)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ b ]pyran-5-yl]heptanoic acid.
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Chronic Idiopathic Constipation
Amitiza┬« is indicated for the treatment of chronic
idiopathic constipation in adults.
Irritable Bowel Syndrome with Constipation
Amitiza is indicated for the treatment of irritable bowel syndrome with
constipation (IBS-C) in women ≥ 18 years old.
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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« Plus GoLYTELY« Versus Placebo Plus GoLYTELY« for Outpatient Colonoscopy Preparation [Completed]
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
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy [Completed]
Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel
preparation can be improved for a good colonoscopic examination without missing lesions and
Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation [Active, not 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.
Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS) [Completed]
Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic
criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a
contributing factor. Changes in motor patterns in the small bowel in IBS patients are
quantitative rather than qualitative with no distinct patterns to distinguish patients from
healthy individuals. Changes in motor patterns can affect transit of bowel contents. Indeed,
variation in intestinal transit was reported in patients with IBS.
Lubiprostone is a novel agent that is Food and Drug Administration (FDA) approved for the
treatment of chronic constipation. More recently 2 randomized double-blind,
placebo-controlled trials showed the drug to be effective in relieving symptoms in patients
with constipation-predominant Irritable Bowel Syndrome (C-IBS), resulting in approval for
female patients with C-IBS at a dose of 8 micrograms twice a day.
The investigators hypothesize that lubiprostone works not just as a laxative, but by
actually altering motility patterns in the small intestine of female patients with C-IBS.
These alterations can be measured through High Resolution Manometry (HRM), a new technique
that uses catheters with multiple closely spaced sensors and special software that uses
color schemes to portray a pressure gradient. This technique allows a detailed assessment of
the direction and spread of contractions. The investigators would like to use HRM to see if
lubiprostone affects intestinal contractions by giving blinded participants lubiprostone and
placebo while they are undergoing High Resolution Manometry and seeing if any changes in
contractions occur. Participants will be recruited from investigator's clinic. If
interested, potential subjects will be provided with a copy of the consent form for review.
Patients will be informed that after they have had an opportunity to review the consent
form, they may contact the study team to further discuss the research and address any
questions/concerns they have.
Participants will undergo a screening visit and a manometry visit. During the screening
visit investigators will determine eligibility, including application of inclusion/exclusion
criteria and administration of a pregnancy test. Then during the manometry visit patients
will receive two capsules, lubiprostone and placebo, three hours apart during HRM. Patients
will receive each capsule only once and will not know which order they're receiving them in.
Amitiza in Constipation Associated With PD (Parkinson's Disease) [Completed]
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.
Reports of Suspected Amitiza (Lubiprostone) Side Effects
Chest Discomfort (26),
Chest Pain (12),
Confusional State (6),
Drug Ineffective (6),
Constipation (6), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Amitiza has an overall score of 6. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Amitiza review by 33 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || IBS|
|Dosage & duration:|| || 12mcg (dosage frequency: 3 times a day) for the period of still taking|
|Other conditions:|| || allergies,chronic back pain, acid reflux|
|Other drugs taken:|| || zyrtec, celexa, nexium|
|Benefits:|| || My stomach aches went away. I wasn't as nauseated as I would have been without anything.|
|Side effects:|| || I have been getting headaches sporadically and the doctor said this is a possbile side effect. Also, I was very nauseated the first 2 weeks, which they say happens in 30% of the population taking this drug, but then it subsided. |
|Comments:|| || I am taking this medication after being diagnosed with Irritable Bowel Syndrome. I was on Zelnorm for this and it was like a miracle drug!! It fixed all my problems for months, then it went off the market. The doctor then told me to try this as an option. It definately helps more than not taking anything at all and I can tell when I get these stomach pains that I forgot to take the drug.|
Amitiza review by 50 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || stomach/digestive disorder|
|Dosage & duration:|| || 24 mcg 2x per day (dosage frequency: daily) for the period of 3 months|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I experienced some alleviation to the constipation but it was not ongoing. It was temporary & it was not regular. I expected that the treatment would be a cure not jsu a temporary relief.|
|Side effects:|| || I felt nauseous & bloated. |
|Comments:|| || I experienced constipation as a side effect to pain meds from surgery. I did not have previous problems with it. It never got better even a long time after the surgery. My doctor recommended I try amitiza after many over the counter products failed. I used it for 3 months. I had some relief but it definitely was not a cure. I quit using the drug since it did not give me significant relief.|
Page last updated: 2016-05-26