The effect of Buspirone on the sensitivity of the esophagus in healthy volunteers.
- Conditions
- altered esophageal sensitivity, gastro-esophageal reflux diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-005059-15-BE
- Lead Sponsor
- uzleuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. age >18 and <60 years
2. no history of gastro-intestinal symptoms
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. a history of allergic reaction to buspirone, or multiple allergies to several foods and drugs
2. pregnancy, lactation
3. concomitant administration of monomine oxidase inhibitors (MAOI), verapamil, or diltiazem, or medications affecting esophageal motility
4. significant commorbidities (neuromuscuar, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
5. prior history of esophageal, ENT or gastric surgery or endoscopic antireflux procedure
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 acute effect of buspirone hydrochloride (Bespar) administered orally as two 10mg tablets, on esophageal sensitivity in healthy volunteers.;Secondary Objective: no secondary objectives;Primary end point(s): Comparison of VAS (visual analogue scores) between healthy volunteers in esophageal stimulation;Timepoint(s) of evaluation of this end point: VAS scores will be compared between active treatment and placebo after completion of both visitis.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): no secondary end point;Timepoint(s) of evaluation of this end point: no secondary end point