The effect of Prucalopride (Resolor) on the stomach motor function and the stomach sensitivity

The effect of Prucalopride (Resolor) on gastric motor function and gastric sensitivity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002705-65-BE

Enrollment

Registered

2013-08-20

Start date

2013-09-26

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia

Interventions

Trade Name: Resolor Pharmaceutical Form: INN or Proposed INN: PRUCALOPRIDE CAS Number: 179474-81-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Volunteers can participate in this study if: • They are between 18-60 years old • Male and female • Patients must provide witnessed written informed consent prior to any study procedures being performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Volunteers cannot participate in this study if: • They are older than 60 years old. • Have severely decreased kidney function. • Have severely decreased liver function. • Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. • Have severe lung disease. • Have severe psychiatric illness or neurological illness. • Have any gastrointestinal disease • Women that are pregnant or breastfeeding. • Have a rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Resolor tablets contain lactose).

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate the effect prucalopride on the gastric motor function. The gastric manometry and the gastric barostat will be used in order to gain more information about its effect on gastric accommodation and gastric sensitivity. ;Secondary Objective: Not applicable;Primary end point(s): The respons of healthy volunteers after administration of prucalopride to evaluate its effect on the stomach in the context of research of new possible therapies in functional dyspepsia patients. ;Timepoint(s) of evaluation of this end point: At visit 4, end of the study for that subject	—

Measure

Time frame

Main Objective: The aim of this study is to investigate the effect prucalopride on the gastric motor function. The gastric manometry and the gastric barostat will be used in order to gain more information about its effect on gastric accommodation and gastric sensitivity. ;Secondary Objective: Not applicable;Primary end point(s): The respons of healthy volunteers after administration of prucalopride to evaluate its effect on the stomach in the context of research of new possible therapies in functional dyspepsia patients. ;Timepoint(s) of evaluation of this end point: At visit 4, end of the study for that subject

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactFlorencia Carbone

TARGID

florencia.carbone@med.kuleuven.be003416330824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026