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
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring reflux disease, heartburn
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
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
NCT ID
NCT01065649
First Posted
February 8, 2010
Last Updated
July 14, 2012
Sponsor
Universidade de Passo Fundo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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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