The role of a hiatal hernia on the efficacy of anti-TLESR therapy in patients with gastroesophageal reflux disease
- Conditions
- Gastroesophageal reflux disease
- Registration Number
- EUCTR2006-003418-16-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- GERD patients (M/F)
- 18-70 years
- typical heartburn symptoms
- daily use of PPI's
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- gastroduodenal surgery in history
- epilepsy in family history
- pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of baclofen compared to placebo on the occurrence of gastroesophageal reflux in GERD patients with or without hiatal hernia.;Secondary Objective: To assess reflux symptoms in the selected patient group;Primary end point(s): The rate of acid and non-acid reflux episodes measured by impedance.
- Secondary Outcome Measures
Name Time Method