CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
Rabeprazole 20mg, placebo dinner and bedtime +2 moredrug
Likely dose
Rabeprazole 20mg, placebo dinner and bedtimefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00539240
NCT00539240Phase 3Completed
CompareCT.gov

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

US Department of Veterans Affairs·interventional·Posted Oct 4, 2007·Updated Aug 18, 2014

In Brief

A Phase 3 clinical trial evaluating Rabeprazole 20mg, placebo dinner and bedtime, Rabeprazole 20 mg two times, Placebo at bedtime, and 1 other intervention for Gastroesophageal Reflux Disease. Completed, enrolled 236 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2007
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2010
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.7 years ago

Interventions

Rabeprazole 20mg, placebo dinner and bedtimedrug

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

Rabeprazole 20 mg two times, Placebo at bedtimedrug

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

Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressantdrug

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