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

Information source: Universidade de Passo Fundo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: Nortriptyline (Drug); Placebo arm (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Universidade de Passo Fundo

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cortical representation of heartburn

Secondary outcome: Subjective assessment of heartburn

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Kozma, Passo Fundo, RS 990010-080, Brazil
Additional Information

Starting date: January 2010
Last updated: July 14, 2012

Page last updated: August 23, 2015

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