Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients (NORGERD)
This study has been completed.
Sponsor:
Universidade de Passo Fundo
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fernando Fornari, Universidade de Passo Fundo
ClinicalTrials.gov Identifier:
NCT01065649
First received: February 8, 2010
Last updated: July 14, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Nortriptyline Drug: Placebo arm |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease |
Resource links provided by NLM:
Further study details as provided by Universidade de Passo Fundo:
Primary Outcome Measures:
- Cortical representation of heartburn [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective assessment of heartburn [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01065649
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065649
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 History of Changes |
| Other Study ID Numbers: | 0102.0.398.000-09 |
| Study First Received: | February 8, 2010 |
| Last Updated: | July 14, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by 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 Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on September 23, 2016