The effect of stress on esophageal sensitivity

The effect of corticotrophin-releasing hormone (CRH) on esophageal sensitivity in healthy volunteers: a randomized, single-blind, placebo-controlled study - The effect of CRH on esophageal sensitivity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000602-36-BE

Enrollment

Registered

2014-02-14

Start date

2014-03-21

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Changed esophageal sensitivity induced by CRH

Interventions

Trade Name: CRH Ferring Product Name: CRH Ferring Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: corticorelin triflutate CAS Number: 121249-14-7 Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 anti-reflux procedure, history of gastrointestinal disease and first degree relatives with Crohn’s disease or celiac disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the effect of CRH-administration on esophageal sensitivity in a group of healthy volunteers;Secondary Objective: not applicable;Primary end point(s): To determine altered esophageal sensitivity after administration of CRH vs placebo;Timepoint(s) of evaluation of this end point: After administration of CRH or placebo	—

Secondary

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

Countries

Belgium

Contacts

Public ContactTARGID

KULeuven

charlotte.broers@med.kuleuven321633 06 71

Outcome results

None listed

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