Lubiprostone

Generic Name: Lubiprostone

Brand Names: Amitiza

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₃₂F_₂O_₅

CAS Number: 136790-76-6

Unique Ingredient Identifier: 7662KG2R6K

Background: Lubiprostone is a medication used in the management of idiopathic chronic constipation. A prostaglandin E1 derivative, lubiprostone is a bicyclic fatty acid that activates ClC-2 chloride channels located on the apical side of the gastrointestinal epithelial cells. Activation of these channels promotes the secretion of a chloride-rich fluid that soften the stool, increase gastrointestinal motility, and induce spontaneous bowel movements (SBM).

Indication: Lubiprostone is indicated for the treatment of adult patients with chronic idiopathic constipation, or opioid-induced constipation in patients with chronic non-cancer pain. It is also indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in female patients ≥18 years old.

Associated Conditions: Irritable Bowel Syndrome With Constipation (IBS-C), Opioid Induced Constipation (OIC), Chronic idiopathic constipation (CIC)

Associated Therapies: -

Clinical Trials

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.

Phase 1

Completed

Conditions: Chronic Constipation, Methanogenesis

Interventions: Drug: Lubiprostone Control
Drug: Lubiprostone

First Posted Date: 2010-08-27

Last Posted Date: 2019-01-15

Lead Sponsor: Augusta University

Target Recruit Count: 41

Registration Number: NCT01190020

Locations: 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸
University of Utah, Salt Lake City, Utah, United States

The Effectiveness of Lubiprostone in Constipated Diabetics

Phase 4

Completed

Conditions: Constipation
Diabetes

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2010-07-27

Last Posted Date: 2016-03-15

Lead Sponsor: Emory University

Target Recruit Count: 121

Registration Number: NCT01170039

Locations: 🇺🇸
Atlanta Veterans Administration Hospital, Atlanta, Georgia, United States
🇺🇸
The Emory Clinic, Atlanta, Georgia, United States

Lubiprostone Effects on Visceral Pain Sensitivity

Phase 1

Completed

Conditions: Irritable Bowel Syndrome

Interventions: Drug: Lubiprostone
Drug: Placebo

First Posted Date: 2010-07-21

Last Posted Date: 2011-09-16

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 62

Registration Number: NCT01166789

Locations: 🇺🇸
UNC Clinical and Translational Research Center, Chapel Hill, North Carolina, United States

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation

Not Applicable

Completed

Conditions: Irritable Bowel Syndrome
Constipation

Interventions: Drug: Placebo
Drug: Lubiprostone
Other: Smartpill wireless motility capsule

First Posted Date: 2010-07-15

Last Posted Date: 2017-01-27

Lead Sponsor: University of Michigan

Target Recruit Count: 60

Registration Number: NCT01162863

Locations: 🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States

Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

Phase 4

Terminated

Conditions: Constipation

Interventions: Drug: lubiprostone
Drug: Matched placebo

First Posted Date: 2010-03-31

Last Posted Date: 2020-11-20

Lead Sponsor: University of South Alabama

Target Recruit Count: 23

Registration Number: NCT01096290

Locations: 🇺🇸
USA Pavilion at Infirmary West, Mobile, Alabama, United States

Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

Not Applicable

Completed

Conditions: Constipation-predominant Irritable Bowel Syndrome

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2010-03-12

Last Posted Date: 2011-12-12

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 4

Registration Number: NCT01085643

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

Lubiprostone, Colonic Motility and Sensation

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: lubiprostone
Drug: Placebo
Other: Bowel preparation

First Posted Date: 2009-08-06

Last Posted Date: 2012-02-27

Lead Sponsor: Mayo Clinic

Target Recruit Count: 60

Registration Number: NCT00953043

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Intestinal Microecology in Chronic Constipation

Phase 1

Completed

Conditions: Other Constipation
Irritable Bowel Syndrome

Interventions: Drug: Lubiprostone

First Posted Date: 2009-07-08

Last Posted Date: 2013-07-17

Lead Sponsor: Mayo Clinic

Target Recruit Count: 21

Registration Number: NCT00934479

Locations: 🇺🇸
Mayo Clinic Arizona, Scottsdale, Arizona, United States

Amitiza in Constipation Associated With PD (Parkinson's Disease)

Phase 4

Completed

Conditions: Parkinson's Disease

Interventions: Drug: LUBIPROSTONE

First Posted Date: 2009-05-25

Last Posted Date: 2022-12-29

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 78

Registration Number: NCT00908076

Locations: 🇺🇸
Baylor College of Medicine PDCMDC, Houston, Texas, United States
🇺🇸
University of South Florida, Tampa, Florida, United States

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: Lubiprostone

First Posted Date: 2009-02-16

Last Posted Date: 2017-07-27

Lead Sponsor: University of Louisville

Target Recruit Count: 25

Registration Number: NCT00844831

Locations: 🇺🇸
University of Louisville, Louisville, Kentucky, United States

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