Changes in esophageal motility induced by CRH-administration
Conditions
Interventions
Trade Name: CRH Ferring
Product Name: CRH Ferring
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
TARGID, KU Leuven
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 antireflux 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 motility in a group of healthy volunteers;Secondary Objective: not applicable;Primary end point(s): To determine altered esophageal motility after administration of CRH compared to baseline conditions;Timepoint(s) of evaluation of this end point: 20 minuten after administration of CRH | — |
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
TARGID, KU Leuven
Outcome results
None listed