Gastroesophageal Reflux Disease
Conditions
Keywords
reflux disease, heartburn
Brief summary
Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment with proton pump inhibitors. The hypothesis of this study was that nortriptyline in analgesic doses may decrease heartburn perception and its corresponding cortical activity measured by magnetic resonance image. Therefore, the aim of this study was to assess the cortical representation of heartburn in patients with NERD under treatment with nortriptyline and placebo.
Interventions
DRUGNortriptyline
It will be administered per oral 10 mg a day in the first 7 days and then 25 mg a day in the last 14 days
DRUGPlacebo arm
Placebo per oral for 21 days, equal to nortriptyline
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade de Passo Fundo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* more than 17 years old, heartburn at least twice a week, naive to antireflux medications and antidepressive agents
Exclusion criteria
* active esophagitis at endoscopy, contraindications to nortriptyline use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortical representation of heartburn | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Subjective assessment of heartburn | 3 months |
Countries
Brazil
Outcome results
None listed