Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients

Universidade de Passo Fundo20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

NortriptylineDRUG

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

Placebo armDRUG

Placebo per oral for 21 days, equal to nortriptyline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kozma

Passo Fundo, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Cortical representation of heartburn

Time frame: 3 months

Secondary Outcomes

Subjective assessment of heartburn

Time frame: 3 months

Data from ClinicalTrials.gov

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