Trial | NCT01065649  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nortriptyline ...

  • Study Participants

    20
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.
Study Started
Jan 31
2010
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Jul 17
2012
Estimate

Drug Placebo arm

Placebo per oral for 21 days, equal to nortriptyline

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

Nortriptyline Experimental

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 Placebo Comparator

Placebo arm

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
No Results Posted