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 st...

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

Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

Phase 3

Completed

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: Lubiprostone
Drug: Placebo

First Posted Date: 2013-11-25

Last Posted Date: 2019-12-13

Lead Sponsor: Mallinckrodt

Target Recruit Count: 164

Registration Number: NCT01993875

Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy

Phase 2

Completed

Conditions: HIV

Interventions: Drug: Lubiprostone

First Posted Date: 2013-04-25

Last Posted Date: 2023-08-30

Lead Sponsor: Ruth M. Rothstein CORE Center

Target Recruit Count: 20

Registration Number: NCT01839734

Locations: 🇺🇸
Ruth M. Rothstein CORE Center, Chicago, Illinois, United States

Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

Phase 3

Completed

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: Lubiprostone
Drug: Placebo

First Posted Date: 2012-08-29

Last Posted Date: 2014-04-03

Lead Sponsor: Dr. Reddy's Laboratories Limited

Target Recruit Count: 909

Registration Number: NCT01674530

Locations: 🇺🇸
Research Integrity, Owensboro, Kentucky, United States
🇺🇸
Bayer Research, Kalamazoo, Michigan, United States
🇺🇸
Mount Vernon Clinical Research, Atlanta, Georgia, United States

and more 82 locations

Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Phase 2

Completed

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: Lubiprostone

First Posted Date: 2011-11-10

Last Posted Date: 2017-06-09

Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Target Recruit Count: 37

Registration Number: NCT01469819

Locations: 🇺🇸
Texas Tech University Health Sciences Center, El Paso, Texas, United States

Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

Phase 4

Completed

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: lubiprostone

First Posted Date: 2011-10-26

Last Posted Date: 2018-07-13

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 19

Registration Number: NCT01460225

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Phase 2

Completed

Conditions: Constipation

Interventions: Drug: lubiprostone
Drug: placebo

First Posted Date: 2011-10-06

Last Posted Date: 2017-06-09

Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Target Recruit Count: 40

Registration Number: NCT01447849

Locations: 🇺🇸
Texas Tech University Health Sciences Center, El Paso, Texas, United States

Evaluation of Clinical Equivalence Between Two Lubiprostone Products

Phase 3

Completed

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: Lubiprostone
Drug: Placebo

First Posted Date: 2011-06-14

Last Posted Date: 2012-07-12

Lead Sponsor: Anchen Pharmaceuticals, Inc

Target Recruit Count: 808

Registration Number: NCT01372423

Locations: 🇺🇸
Novum Investigator Site, Mountain Lake, Washington, United States
🇺🇸
Novum Invesitgator Site, Hollywood, Maryland, United States

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Phase 3

Completed

Conditions: Colorectal Carcinoma

Interventions: Drug: Lubiprostone

First Posted Date: 2011-03-29

Last Posted Date: 2013-04-05

Lead Sponsor: Asian Institute of Gastroenterology, India

Target Recruit Count: 442

Registration Number: NCT01324284

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

Phase 3

Completed

Conditions: Opioid-induced Bowel Dysfunction

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2011-02-17

Last Posted Date: 2020-02-11

Lead Sponsor: Sucampo Pharma Americas, LLC

Target Recruit Count: 439

Registration Number: NCT01298219

Locations: 🇺🇸
Hartwell Research Group, Anderson, South Carolina, United States
🇺🇸
North Alabama Research Center, Athens, Alabama, United States
🇺🇸
Sunstone Medical Research, Medford, Oregon, United States

and more 137 locations

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Phase 4

Completed

Conditions: Constipation
Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2010-11-08

Last Posted Date: 2015-12-10

Lead Sponsor: University of Rochester

Target Recruit Count: 21

Registration Number: NCT01236534

Locations: 🇺🇸
University of Rochester, Rochester, New York, United States

Drug Development Updates

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