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

Universidade de Passo Fundo

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Placebo arm; Drug: Nortriptyline

Study type: Interventional

Funder types: Other

Identifiers

NCT01065649

0102.0.398.000-09

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Nortriptyline

Experimental group

Description:

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

Treatment:

Drug: Nortriptyline

Placebo

Placebo Comparator group

Description:

Placebo arm

Treatment:

Drug: Nortriptyline

Drug: Placebo arm