Effect of impaired stomach relaxation on reflux

Phase 1

• Conditions: Impaired gastric accommodation; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-000532-17-BE
• Lead Sponsor: K.U. Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-10-12
• Study Start: 2016-02-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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 25
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 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 methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects;Secondary Objective: Not applicable;Primary end point(s): To determine the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events;Timepoint(s) of evaluation of this end point: After administration of methylnaltrexone

Secondary Outcome Measures

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