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Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI

NCT00539240 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2014-08-18

Study results available
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Summary

The purpose of this project is to compare the efficacy (how successful) 1) standard-dose proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline 50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI (rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to determine the relative symptom resolution and health-related quality of life in gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn) behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD) patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a coin) to one of the three groups.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Rabeprazole 20mg, placebo dinner and bedtime

Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime

DRUG

Rabeprazole 20 mg two times, Placebo at bedtime

Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime

DRUG

Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant

Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-04-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539240 on ClinicalTrials.gov