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
Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
- Conditions
- Functional Constipation
- Interventions
- Drug: YH12852 IR 0.1mgDrug: YH12852 DR1 2mgDrug: YH12852 IR 0.05mgDrug: YH12852 IR 0.5mgDrug: YH12852 IR 2mgDrug: YH12852 IR 0.3mgDrug: YH12852 IR 1mgDrug: PlaceboDrug: YH12852 IR 3mgDrug: YH12852 DR1 0.5mgDrug: YH12852 DR1 1mgDrug: YH12852 DR1 4mgDrug: YH12852 DR2 8mg
- First Posted Date
- 2015-09-02
- Last Posted Date
- 2016-10-31
- Lead Sponsor
- Yuhan Corporation
- Target Recruit Count
- 120
- Registration Number
- NCT02538367
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
Prucalopride Versus Placebo in Gastroparesis
- First Posted Date
- 2015-07-29
- Last Posted Date
- 2024-07-10
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Target Recruit Count
- 60
- Registration Number
- NCT02510976
- Locations
- 🇧🇪
University Hospitals, Leuven, Vlaanderen, Belgium
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
- Conditions
- Postoperative Ileus
- Interventions
- First Posted Date
- 2015-04-24
- Last Posted Date
- 2023-02-08
- Lead Sponsor
- KU Leuven
- Target Recruit Count
- 30
- Registration Number
- NCT02425774
- Locations
- 🇧🇪
University hospitals Leuven, Leuven, Vlaams-Brabant, Belgium
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
- Conditions
- Constipation
- Interventions
- First Posted Date
- 2014-08-29
- Last Posted Date
- 2017-09-15
- Lead Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Target Recruit Count
- 280
- Registration Number
- NCT02228616
Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
- First Posted Date
- 2014-01-28
- Last Posted Date
- 2021-03-22
- Target Recruit Count
- 560
- Registration Number
- NCT02047045
Prucalopride Versus Placebo in Gastroparesis
- Conditions
- GastroparesisDiabetes Mellitus
- Interventions
- 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
- 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
- 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?
- 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
- Conditions
- Bowel CleansingColon Capsule Completion Times
- Interventions
- 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
Drug Development Updates
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