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

History of Changes

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 Intervention Model: Crossover Assignment Masking: Triple (Participant, 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:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Fernando Fornari, Universidade de Passo Fundo:

Primary Outcome Measures:

Cortical representation of heartburn [ Time Frame: 3 months ]

Secondary Outcome Measures:

Subjective assessment of heartburn [ Time Frame: 3 months ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Fernando Fornari, 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	Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017

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