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

Associated Therapies: -

Clinical Trials

Prucalopride Versus Placebo in Gastroparesis

Phase 2

Completed

Conditions: Gastroparesis
Diabetes Mellitus

Interventions: Drug: Prucalopride
Drug: Placebo

First Posted Date: 2014-01-09

Last Posted Date: 2020-10-08

Lead Sponsor: University of Calgary

Target Recruit Count: 15

Registration Number: NCT02031081

Locations: 🇨🇦
University of Calgary, Calgary, Alberta, Canada

Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

Phase 2

Completed

Conditions: Postoperative Ileus

Interventions: Drug: Placebo
Drug: Prucalopride

First Posted Date: 2013-12-09

Last Posted Date: 2016-09-30

Lead Sponsor: Jinling Hospital, China

Target Recruit Count: 110

Registration Number: NCT02004652

Locations: 🇨🇳
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University, Nanjing, Jiangsu, China

Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: YH12852
Drug: Prucalopride

First Posted Date: 2013-06-06

Last Posted Date: 2015-05-08

Lead Sponsor: Yuhan Corporation

Target Recruit Count: 127

Registration Number: NCT01870674

Locations: 🇰🇷
Inje Busan Paik hospital, Busan, Korea, Republic of

The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?

Withdrawn

Conditions: Constipation

Interventions: Drug: Prucalopride

First Posted Date: 2013-06-05

Last Posted Date: 2020-04-24

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Registration Number: NCT01869751

Locations: 🇧🇪
University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule

Phase 3

Completed

Conditions: Bowel Cleansing
Colon Capsule Completion Times

Interventions: Drug: Prucalopride
Procedure: Colon Capsule

First Posted Date: 2013-05-30

Last Posted Date: 2017-02-16

Lead Sponsor: Queen's University

Target Recruit Count: 60

Registration Number: NCT01864915

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

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