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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Nortriptyline
Placebo arm
Sponsored by
Universidade de Passo Fundo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring reflux disease, heartburn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kozma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nortriptyline

Placebo

Arm Description

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

Placebo arm

Outcomes

Primary Outcome Measures

Cortical representation of heartburn

Secondary Outcome Measures

Subjective assessment of heartburn

Full Information

First Posted
February 8, 2010
Last Updated
July 14, 2012
Sponsor
Universidade de Passo Fundo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01065649
Brief Title
Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients
Acronym
NORGERD
Official Title
Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade de Passo Fundo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
reflux disease, heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nortriptyline
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
Nortriptyline
Intervention Description
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
Intervention Name(s)
Placebo arm
Intervention Description
Placebo per oral for 21 days, equal to nortriptyline
Primary Outcome Measure Information:
Title
Cortical representation of heartburn
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Subjective assessment of heartburn
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kozma
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
990010-080
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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