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

Gastroesophageal Reflux Disease Clinical Trial

— NORGERD  

Official title:

Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065649
• Other study ID #: 0102.0.398.000-09
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: July 14, 2012
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2012
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn

Intervention

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 arm
Placebo per oral for 21 days, equal to nortriptyline

Locations

Country	Name	City	State
Brazil	Kozma	Passo Fundo	RS

Sponsors (2)

Lead Sponsor	Collaborator
Universidade de Passo Fundo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical representation of heartburn		3 months	No
Secondary	Subjective assessment of heartburn		3 months	No