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

• ClinicalTrials.gov Identifier: NCT01065649
• Recruitment Status: Completed
• First Posted: February 9, 2010
• Last Update Posted: July 17, 2012
• Sponsor: Universidade de Passo Fundo
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Information provided by (Responsible Party): Fernando Fornari, Universidade de Passo Fundo

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.

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Disease	Drug: Nortriptyline; Drug: Placebo arm	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• 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
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Cortical representation of heartburn [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Subjective assessment of heartburn [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 0102.0.398.000-09
• First Posted: February 9, 2010
• Last Update Posted: July 17, 2012
• Last Verified: July 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; 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