Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Drug: Placebo arm
- Registration Number
- NCT01065649
- Lead Sponsor
- Universidade de Passo Fundo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo arm Placebo arm Nortriptyline Nortriptyline 20 NERD patients will be treated with nortriptyline 10 mg a day in the first 7 days and 25 mg a day in the following 14 days Placebo Nortriptyline Placebo arm
- Primary Outcome Measures
Name Time Method Cortical representation of heartburn 3 months
- Secondary Outcome Measures
Name Time Method Subjective assessment of heartburn 3 months
Trial Locations
- Locations (1)
Kozma
🇧🇷Passo Fundo, RS, Brazil