The effect of acute stress on esophageal motility

Phase 1

• Conditions: Changes in esophageal motility induced by CRH-administration; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-002239-33-BE
• Lead Sponsor: TARGID, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-29
• Study Completion: 2014-12-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Healthy volunteers aged between 18-60 years
No history of gastrointestinal symptoms or complaints.
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history of allergic reaction to CRH,
2.atopy (eczema, asthma, food allergies, allergic rhinoconjunctivis) or
multiple allergies to several drugs,
3. pregnancy or lactation,
4.concomitant administration of monoamine oxidase inhibitors (MAOI),
verapamil or diltiazem or medication affecting esophageal motility,
5. significant co-morbidities (neuromuscular, psychiatric, cardiovascular,
pulmonary, endocrine, autoimmune, renal and hepatic),
6. prior history of esophageal, ENT or gastric surgery or endoscopic antireflux
procedure, history of gastrointestinal disease and first degree
relatives with Crohn's disease or celiac disease.

Study & Design

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