NCT01065649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

February 8, 2010

Last Update Submit

July 14, 2012

Conditions

Gastroesophageal Reflux Disease

Keywords

reflux diseaseheartburn

Outcome Measures

Primary Outcomes (1)

  • Cortical representation of heartburn

    3 months

Secondary Outcomes (1)

  • Subjective assessment of heartburn

    3 months

Study Arms (2)

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

Drug: Nortriptyline

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: NortriptylineDrug: Placebo arm

Interventions

NortriptylineDRUG

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

NortriptylinePlacebo
Placebo armDRUG

Placebo per oral for 21 days, equal to nortriptyline

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 17 years old, heartburn at least twice a week, naive to antireflux medications and antidepressive agents

You may not qualify if:

  • active esophagitis at endoscopy, contraindications to nortriptyline use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kozma

Passo Fundo, Rio Grande do Sul, 990010-080, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Interventions

Nortriptyline

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

BR(1)