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

The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome

Phase 2

Conditions: Irritable Bowel Syndrome

Interventions: Drug: Prucalopride 2mg

First Posted Date: 2021-02-17

Last Posted Date: 2021-10-22

Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Target Recruit Count: 160

Registration Number: NCT04757493

Locations: 🇧🇩
Shahbag, Dhaka, Bangladesh

The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Not Applicable

Completed

Conditions: Gastrointestinal Motility Disorder
Dyspepsia

Interventions: Drug: Placebo
Drug: Prucalopride

First Posted Date: 2020-06-12

Last Posted Date: 2021-10-26

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 17

Registration Number: NCT04429802

Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Phase 3

Conditions: Paralytic Ileus
Critically Ill

Interventions: Drug: Placebo
Drug: Prucalopride

First Posted Date: 2019-12-09

Last Posted Date: 2020-02-06

Lead Sponsor: Prince of Songkla University

Target Recruit Count: 62

Registration Number: NCT04190173

Locations: 🇹🇭
Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand

Effects of Acute Prucalopride Administration in Healthy Volunteers

Not Applicable

Completed

Conditions: Mood Disorders
Mental Disorder
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Depression
Depressive Disorder
Cognition

Interventions: Other: Placebo
Drug: Prucalopride

First Posted Date: 2019-03-05

Last Posted Date: 2019-03-05

Lead Sponsor: University of Oxford

Target Recruit Count: 41

Registration Number: NCT03863366

Locations: 🇬🇧
University of Oxford, Oxford, United Kingdom

Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

Phase 4

Conditions: GERD

Interventions: Drug: Placebo Oral Tablet
Drug: Prucalopride

First Posted Date: 2018-09-18

Last Posted Date: 2019-12-05

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 60

Registration Number: NCT03676374

Locations: 🇧🇪
UZ Leuven, Leuven, Belgium

Effects of Seven Day Prucalopride Administration in Healthy Volunteers

Not Applicable

Completed

Conditions: Depression
Depressive Disorder
Mood Disorders
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Antidepressive Agents
Cognition