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

Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

Phase 4

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Lubiprostone
Drug: Placebo

First Posted Date: 2008-09-04

Last Posted Date: 2020-10-08

Lead Sponsor: University of South Alabama

Target Recruit Count: 45

Registration Number: NCT00746395

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

Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis

Not Applicable

Completed

Conditions: Constipation
Cystic Fibrosis

First Posted Date: 2008-06-27

Last Posted Date: 2011-04-18

Lead Sponsor: University of Arkansas

Target Recruit Count: 9

Registration Number: NCT00706004

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Efficacy of Lubiprostone in Combination With Standard PEG Preparation

Not Applicable

Terminated

Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions: Other: Polyethylene glycol with electrolytes
Drug: Lubiprostone

First Posted Date: 2008-06-03

Last Posted Date: 2014-10-20

Lead Sponsor: Augusta University

Target Recruit Count: 60

Registration Number: NCT00689026

Locations: 🇺🇸
Medical College of Georgia, Augusta, Georgia, United States

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Not Applicable

Terminated

Conditions: Parkinson's Disease
Constipation

Interventions: Drug: Lubiprostone

First Posted Date: 2008-04-30

Last Posted Date: 2016-12-30

Lead Sponsor: University of Arkansas

Target Recruit Count: 1

Registration Number: NCT00669461

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

Not Applicable

Completed

Conditions: Constipation

Interventions: Drug: Senna
Drug: Lubiprostone

First Posted Date: 2008-04-21

Last Posted Date: 2013-03-06

Lead Sponsor: Shirley Ryan AbilityLab

Target Recruit Count: 64

Registration Number: NCT00662363

Locations: 🇺🇸
Rehabilitation Institute of Chicago, Chicago, Illinois, United States

Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Not Applicable

Completed

Conditions: Bowel Preparation for Colonoscopy

Interventions: Drug: placebo
Drug: lubiprostone

First Posted Date: 2008-02-11

Last Posted Date: 2012-11-01

Lead Sponsor: Brooke Army Medical Center

Target Recruit Count: 191

Registration Number: NCT00611442

Locations: 🇺🇸
Brooke Army Medical Center, Fort Sam Houston, Texas, United States

Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

Phase 3

Completed

Conditions: Opioid-Induced Bowel Dysfunction

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2008-01-18

Last Posted Date: 2019-12-10

Lead Sponsor: Sucampo Pharma Americas, LLC

Target Recruit Count: 437

Registration Number: NCT00597428

Locations: 🇺🇸
Claude Mandel Medical Center, Chicago, Illinois, United States
🇺🇸
Jeffry A. Lindenbaum DO, PC, Yardley, Pennsylvania, United States
🇺🇸
Hampton Roads Institute for Performance and Sports Medicine (HIPS), Portsmouth, Virginia, United States

and more 110 locations

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Phase 3

Completed

Conditions: Opioid-Induced Bowel Dysfunction

Interventions: Drug: Placebo
Drug: Lubiprostone

First Posted Date: 2008-01-16

Last Posted Date: 2019-12-16

Lead Sponsor: Sucampo Pharma Americas, LLC

Target Recruit Count: 439

Registration Number: NCT00595946

Locations: 🇺🇸
Orange County Clinical Trials, Inc., Anaheim, California, United States
🇺🇸
Apex Medical Research, AMR, Inc., Flint, Michigan, United States
🇺🇸
Medoff Medical/ Vital re:Search, Greensboro, North Carolina, United States

and more 90 locations

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: Lubiprostone

First Posted Date: 2007-03-27

Last Posted Date: 2019-12-17

Lead Sponsor: Sucampo Pharma Americas, LLC

Target Recruit Count: 127

Registration Number: NCT00452335

Locations: 🇺🇸
University of Illinois at Chicago, Springfield, Illinois, United States
🇺🇸
Arkansas Pediatric Clinic, Little Rock, Arkansas, United States
🇺🇸
AHS Hospital Corporation, Morristown, New Jersey, United States

and more 16 locations

Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Phase 3

Completed

Conditions: Constipation
Irritable Bowel Syndrome

First Posted Date: 2006-11-15

Last Posted Date: 2019-12-17

Lead Sponsor: Sucampo Pharma Americas, LLC

Target Recruit Count: 581

Registration Number: NCT00399542

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