Lubiprostone

Generic Name
Lubiprostone
Brand Names
Amitiza
Drug Type
Small Molecule
Chemical Formula
C20H32F2O5
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
-

Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

First Posted Date
2018-10-25
Last Posted Date
2022-03-02
Lead Sponsor
BioDelivery Sciences International
Target Recruit Count
34532
Registration Number
NCT03720613
Locations
🇺🇸

Research Site, Wilmington, Delaware, United States

Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

First Posted Date
2017-03-31
Last Posted Date
2020-01-14
Lead Sponsor
Sucampo Pharma Americas, LLC
Target Recruit Count
552
Registration Number
NCT03097861
Locations
🇺🇸

Investigative Site, Richmond, Virginia, United States

🇺🇸

Investigative Sitee, High Point, North Carolina, United States

🇺🇸

Investigative Site 2, Jackson, Tennessee, United States

Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-05-10
Last Posted Date
2020-05-15
Lead Sponsor
Sucampo Pharma Americas, LLC
Target Recruit Count
87
Registration Number
NCT02766777
Locations
🇺🇸

Northwest Arkansas Pediatric Clinic, Fayetteville, Arkansas, United States

🇺🇸

Pioneer Clinical Research, Bellevue, Nebraska, United States

🇺🇸

Methodist Medical Center, Peoria, Illinois, United States

and more 10 locations

Lubiprostone for Chronic Idiopathic Constipation Treatment

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-04-06
Last Posted Date
2019-04-01
Lead Sponsor
Takeda
Target Recruit Count
211
Registration Number
NCT02729909

Lubiprostone for Treatment of Chronic Idiopathic Constipation

First Posted Date
2016-03-01
Last Posted Date
2018-12-31
Lead Sponsor
Takeda
Target Recruit Count
156
Registration Number
NCT02695719

Lubiprostone for the Treatment of Chronic Idiopathic Constipation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-01-08
Last Posted Date
2018-08-13
Lead Sponsor
Takeda
Target Recruit Count
204
Registration Number
NCT02651155

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2015-09-09
Last Posted Date
2019-12-27
Lead Sponsor
Sucampo Pharma Americas, LLC
Target Recruit Count
71
Registration Number
NCT02544152
Locations
🇺🇸

E Squared Research, Inc., Huntsville, Alabama, United States

🇺🇸

Inland Empire Liver Foundation, Rialto, California, United States

🇺🇸

Wake Research Associates, LLC, Raleigh, North Carolina, United States

and more 12 locations

A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

First Posted Date
2015-06-25
Last Posted Date
2020-07-27
Lead Sponsor
Braintree Laboratories
Target Recruit Count
459
Registration Number
NCT02481947
Locations
🇺🇸

BLI Research Site 12, Artesia, California, United States

🇺🇸

BLI Research Site 13, Laguna Hills, California, United States

🇺🇸

BLI Research Site 47, Owensboro, Kentucky, United States

and more 47 locations

Lubiprostone for Children With Constipation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-05-14
Last Posted Date
2020-01-21
Lead Sponsor
Sucampo Pharma Americas, LLC
Target Recruit Count
419
Registration Number
NCT02138136
Locations
🇺🇸

Gastrointestinal Associates, PA, Jackson, Mississippi, United States

🇺🇸

Children's Hospital of Pittsburgh UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

and more 82 locations

Lubiprostone in Children With Functional Constipation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-01-22
Last Posted Date
2020-07-21
Lead Sponsor
Sucampo Pharma Americas, LLC
Target Recruit Count
606
Registration Number
NCT02042183
Locations
🇺🇸

Loma Linda University Health Care, Loma Linda, California, United States

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

and more 113 locations
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