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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

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

Phase 2
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2008-02-18
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
174
Registration Number
NCT00617513

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

Phase 3
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2008-01-21
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
516
Registration Number
NCT00598338

Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

Phase 2
Completed
Conditions
Constipation
Interventions
First Posted Date
2008-01-17
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
313
Registration Number
NCT00596596

Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of Chronic Constipation

Phase 3
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2007-12-19
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
755
Registration Number
NCT00577018

Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation

Phase 2
Completed
Conditions
Chronic Constipation
Interventions
Drug: placebo
First Posted Date
2007-12-19
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
53
Registration Number
NCT00576511

Prucalopride in Patients With Chronic Idiopathic Constipation

Phase 2
Completed
Conditions
Constipation
Interventions
Drug: placebo
First Posted Date
2007-12-18
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
87
Registration Number
NCT00575614

A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride

Phase 1
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2007-06-20
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
32
Registration Number
NCT00488215

Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

Phase 3
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2007-06-19
Last Posted Date
2013-09-26
Lead Sponsor
Movetis
Target Recruit Count
716
Registration Number
NCT00488137

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

Phase 3
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2007-06-18
Last Posted Date
2008-05-29
Lead Sponsor
Movetis
Target Recruit Count
303
Registration Number
NCT00487422

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

Phase 3
Completed
Conditions
Constipation
Interventions
Other: Placebo
First Posted Date
2007-06-13
Last Posted Date
2013-09-25
Lead Sponsor
Movetis
Target Recruit Count
641
Registration Number
NCT00485940
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