Skip to main content
OpenTrials
Completed

NCT Number: NCT01065649

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kozma

Passo Fundo, Rio Grande do Sul, 990010-080, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nortriptyline

Drug

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 arm

Drug

Placebo per oral for 21 days, equal to nortriptyline

Primary outcomes

  1. Cortical representation of heartburn

    Time frame: 3 months

Secondary outcomes

  1. Subjective assessment of heartburn

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease

Acronym: NORGERD

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2010
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.