The effect of dopamine receptor blocking on esophageal sensitivity in healthy volunteers

Phase 1

• Conditions: Increased esophageal sensitivity in refractory gastro-esophageal reflux disease; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-003131-38-BE
• Lead Sponsor: TARGID, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Study Completion: 2017-10-19
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

age > 18 and <65 years
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 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history of any upper GI symptoms or GI surgery
2. Psychological disorders
3. Any drug history
4. Use of medication altering esophageal or GI motility
5.Pregnant or nursing women

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of chlorpromazine (Largactil) on esophageal sensitivity in healthy subjects;Secondary Objective: not applicable;Primary end point(s): To assess the effect of chlorpromazine (Largactil) on esophageal sensitivity in healthy subjects by using a multimodal stimulation protocol;Timepoint(s) of evaluation of this end point: after administration of chlorpromazine (Largatil)

Secondary Outcome Measures

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