Prucalopride

Generic Name: Prucalopride

Brand Names: Motegrity, Resolor, Resotran

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₆ClN_₃O_₃

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

Clinical Trials

Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

Phase 4

Completed

Conditions: Chronic Constipation

Interventions: Drug: PEG 3350
Drug: prucalopride

First Posted Date: 2012-10-16

Last Posted Date: 2021-07-02

Lead Sponsor: Shire

Target Recruit Count: 13

Registration Number: NCT01707667

Locations: 🇧🇪
UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg, Leuven, Belgium
🇺🇸
Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, United States
🇬🇧
Barts Health NHS Trust, Whitechapel, London, United Kingdom

A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation

Withdrawn

Conditions: Chronic Constipation

Interventions: Drug: Prucalopride

First Posted Date: 2012-09-25

Last Posted Date: 2015-12-02

Lead Sponsor: Janssen Pharmaceutica

Registration Number: NCT01692132

Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Phase 1

Completed

Conditions: Constipation

Interventions: Drug: prucalopride

First Posted Date: 2012-08-28

Last Posted Date: 2012-08-28

Lead Sponsor: Movetis

Target Recruit Count: 38

Registration Number: NCT01674166

Prucalopride Subjects With Renal Impairment

Phase 1

Completed

Conditions: Constipation

Interventions: Drug: prucalopride

First Posted Date: 2012-08-28

Last Posted Date: 2012-08-28

Lead Sponsor: Movetis

Target Recruit Count: 34

Registration Number: NCT01674192

Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Phase 1

Completed

Conditions: Constipation

Interventions: Drug: prucalopride

First Posted Date: 2012-08-22

Last Posted Date: 2012-08-22

Lead Sponsor: Movetis

Target Recruit Count: 37

Registration Number: NCT01670669

Improving Bowel Preparation for the Colon Capsule

Phase 3

Completed

Conditions: Quality of Bowel Preparation for the Colon Capsule
Colon Capsule Completion Rates
Colon Capsule Polyp Detection

Interventions: Drug: PEG
Drug: Prucalopride
Drug: Picosalax
Procedure: Colon capsule
Drug: Bisacodyl
Procedure: Colonoscopy

First Posted Date: 2012-08-01

Last Posted Date: 2015-12-03

Lead Sponsor: Queen's University

Target Recruit Count: 20

Registration Number: NCT01655095

Locations: 🇨🇦
Hotel Dieu Hospital, Kingston, Ontario, Canada

Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: placebo
Drug: prucalopride

First Posted Date: 2011-08-26

Last Posted Date: 2021-06-11

Lead Sponsor: Shire

Target Recruit Count: 364

Registration Number: NCT01424228

Locations: 🇭🇺
Békés Megyei Képviselotestület Pándy Kálmán Kórháza, Gyula, Bekes, Hungary
🇵🇱
Krakowskie Centrum Medyczne NZOZ, Krakow, Malopolskie, Poland
🇵🇱
Endoskopia Sp. z o.o., Sopot, Pomorskie, Poland

and more 57 locations

Prucalopride in Pediatric Subjects With Functional Constipation

Phase 3

Completed

Conditions: Functional Constipation

Interventions: Drug: PEG 4000
Drug: Placebo
Drug: prucalopride

First Posted Date: 2011-04-06

Last Posted Date: 2021-06-10

Lead Sponsor: Shire

Target Recruit Count: 215

Registration Number: NCT01330381

Locations: 🇳🇱
Academisch Medisch Centrum, Amsterdam, Netherlands

Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation

Phase 3

Completed

Conditions: Constipation

Interventions: Drug: PEG 3350 plus electrolytes
Drug: Prucalopride

First Posted Date: 2010-12-02

Last Posted Date: 2012-08-31

Lead Sponsor: Norgine

Target Recruit Count: 240

Registration Number: NCT01251822

Locations: 🇷🇴
Pierrel Research, Timisoara, Romania

Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

Phase 3

Completed

Conditions: Male Subjects With Chronic Constipation

Interventions: Drug: Placebo
Drug: Prucalopride

First Posted Date: 2010-06-22

Last Posted Date: 2021-06-10

Lead Sponsor: Shire

Target Recruit Count: 374

Registration Number: NCT01147926

Locations: 🇧🇪
Cliniques Universitaires St Luc, Bruxelles, Belgium
🇧🇪
CHU Sart Tilman, Liege, Belgium
🇳🇱
Meander Medisch Centrum, Amersfoort, Netherlands

and more 68 locations

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