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Prucalopride

Generic Name
Prucalopride
Brand Names
Motegrity, Resolor, Resotran
Drug Type
Small Molecule
Chemical Formula
C18H26ClN3O3
CAS Number
179474-81-8
Unique Ingredient Identifier
0A09IUW5TP
Background

Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009, in Canada on December 7, 2011 and by the FDA on December 17, 2018.

Indication

Prucalopride is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

CIC is one of the most common chronic functional gastrointestinal disorders worldwide. The diagnosis of this agent is very hard and it can be confirmed if the patient experience at least two of the following:

-Straining during more than 25% of the bowel movements.

-Lumpy or hard stools in 25% of the bowel movements.

-Sensation of incomplete evacuation in more than 25% of all bowel movements.

-Sensation of anorectal blockage or obstruction in more than 25% of the bowel movements.

-Manual maneuvers required in more than 25% of the bowel movements.

-Fewer than 3 bowel movements per week.

Associated Conditions
Opioid Induced Constipation (OIC), Chronic idiopathic constipation (CIC), Refractory Chronic idiopathic constipation

Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2010-05-31
Last Posted Date
2012-04-19
Lead Sponsor
Movetis
Target Recruit Count
24
Registration Number
NCT01134185

Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Phase 3
Terminated
Conditions
Non-cancer Pain
Opioid Induced Constipation
Interventions
Drug: placebo
First Posted Date
2010-05-05
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
174
Registration Number
NCT01117051

An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation

Phase 3
Completed
Conditions
Constipation
Interventions
Drug: Placebo
First Posted Date
2010-05-04
Last Posted Date
2017-03-21
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
507
Registration Number
NCT01116206

Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

Phase 3
Completed
Conditions
Chronic Constipation
First Posted Date
2010-02-18
Last Posted Date
2010-03-02
Lead Sponsor
Movetis
Target Recruit Count
693
Registration Number
NCT01070615
Locations
🇧🇪

University Hospital Antwerp, Edegem, Belgium

M0001 Effects on Oral Contraceptive Plasma Levels

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2009-12-21
Last Posted Date
2011-05-17
Lead Sponsor
Movetis
Target Recruit Count
16
Registration Number
NCT01036893
Locations
🇩🇪

FOCUS GmbH, Neuss, Germany

Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Phase 3
Completed
Conditions
Chronic Constipation
First Posted Date
2009-10-01
Last Posted Date
2009-10-01
Lead Sponsor
Movetis
Target Recruit Count
1775
Registration Number
NCT00987844
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

Phase 1
Completed
Conditions
Constipation
Interventions
First Posted Date
2009-05-18
Last Posted Date
2009-05-18
Lead Sponsor
Movetis
Target Recruit Count
120
Registration Number
NCT00903747

Safety Study of Prucalopride in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
First Posted Date
2008-11-19
Last Posted Date
2008-11-21
Lead Sponsor
Movetis
Registration Number
NCT00793429

Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

Phase 2
Completed
Conditions
Constipation
Interventions
Drug: Placebo
First Posted Date
2008-03-10
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
253
Registration Number
NCT00631813

Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility

Phase 2
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2008-03-03
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
100
Registration Number
NCT00627692
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