NCT00251732

Brief Summary

The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 19, 2010

Status Verified

August 1, 2010

Enrollment Period

5.2 years

First QC Date

November 8, 2005

Last Update Submit

August 18, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

acid reflux studiesefficacy of PPI therapyfailing PPI therapyGERDAcid Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Symptom control after 6 weeks of treatment

    To measure the outcome after 6 weeks of treatment

    6 weeks

Secondary Outcomes (3)

  • Number of drop-outs due to poor symptom control

    6 weeks

  • Level of antacid consumption

    6 weeks

  • Improvement in quality of life

    6 weeks

Study Arms (3)

Standard dose (PPI) plus low dose TCA

ACTIVE COMPARATOR

Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)

Drug: Standard dose (once daily) PPI plus low-dose antidepressant

Double dose PPI

ACTIVE COMPARATOR

Double dose proton pump inhibitor plus placebo

Drug: Double dose PPI plus evening placebo

Standard dose PPI plus placebo x 2

PLACEBO COMPARATOR

Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime

Drug: Rabeprazole , placebo, placebo

Interventions

Standard dose (once daily) PPI plus low-dose antidepressantDRUG

20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)

Also known as: Aciphex-PPI, Nortriptyline-TCA
Standard dose (PPI) plus low dose TCA
Double dose PPI plus evening placeboDRUG

20 mg. twice daily with a placebo

Also known as: Aciphex-PPI, rabeprazole
Double dose PPI
Rabeprazole , placebo, placeboDRUG

20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime

Also known as: Aciphex-rabeprazole (PPI), Nortriptyline-low-dose tricyclic antidepressant (TCA)
Standard dose PPI plus placebo x 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Ages 18 to 75
  • At least two episodes of heartburn per week while on PPI once daily
  • Able to communicate with the investigator and comply with the requirements of the study
  • Subjects who give written informed consent after being given a full description of the study.

You may not qualify if:

  • Known allergy or intolerance to TCA
  • Use of antidepressant or a diagnosis of depression
  • History of serious arrhythmia or use of anti-arrhythmics
  • History of seizures
  • Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
  • Evidence or history of drug abuse within the past 6 months
  • Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
  • History of esophagogastric surgery
  • Gastric or duodenal lesions (ulcer, tumor, etc)
  • Women who are pregnant or of childbearing age who are not on contraception
  • Patients who are unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Antidepressive AgentsRabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ronnie Fass, MD

    SAVAHCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

March 1, 2005

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 19, 2010

Record last verified: 2010-08

Locations

US(1)