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

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fernando Fornari, Universidade de Passo Fundo
ClinicalTrials.gov Identifier:
NCT01065649
First received: February 8, 2010
Last updated: July 14, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Nortriptyline
Drug: Placebo arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease

Resource links provided by NLM:


Further study details as provided by Universidade de Passo Fundo:

Primary Outcome Measures:
  • Cortical representation of heartburn [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective assessment of heartburn [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Nortriptyline
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 Comparator: Placebo
Placebo arm
Drug: Nortriptyline
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
Drug: Placebo arm
Placebo per oral for 21 days, equal to nortriptyline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065649

Locations
Brazil
Kozma
Passo Fundo, RS, Brazil, 990010-080
Sponsors and Collaborators
Universidade de Passo Fundo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
  More Information

No publications provided

Responsible Party: Fernando Fornari, PhD, Universidade de Passo Fundo
ClinicalTrials.gov Identifier: NCT01065649     History of Changes
Other Study ID Numbers: 0102.0.398.000-09
Study First Received: February 8, 2010
Last Updated: July 14, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade de Passo Fundo:
reflux disease
heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Nortriptyline
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014