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

NCT ID: NCT01065649

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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reflux disease heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Nortriptyline

Intervention Type 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

Placebo arm

Group Type PLACEBO_COMPARATOR

Nortriptyline

Intervention Type 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

Intervention Type DRUG

Placebo per oral for 21 days, equal to nortriptyline

Interventions

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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

Intervention Type DRUG

Placebo arm

Placebo per oral for 21 days, equal to nortriptyline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade de Passo Fundo

OTHER

Sponsor Role lead

Responsible Party

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Fernando Fornari

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kozma

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0102.0.398.000-09

Identifier Type: -

Identifier Source: org_study_id