Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients (NORGERD)
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ClinicalTrials.gov Identifier: NCT01065649 |
Recruitment Status
:
Completed
First Posted
: February 9, 2010
Last Update Posted
: July 17, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Disease | Drug: Nortriptyline Drug: Placebo arm | Phase 3 |
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 |
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
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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
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Placebo Comparator: Placebo
Placebo arm
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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
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- Cortical representation of heartburn [ Time Frame: 3 months ]
- Subjective assessment of heartburn [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065649
Brazil | |
Kozma | |
Passo Fundo, RS, Brazil, 990010-080 |
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 |
First Posted: | February 9, 2010 Key Record Dates |
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 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 |