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

Phase 1

• Conditions: Functional dyspepsia; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-002705-65-BE
• Lead Sponsor: TARGID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-20
• Study Completion: 2015-07-27
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate the effect prucalopride on the gastric motor function. <br>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. <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable