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NCT00539240 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 2
Development phase
236
Enrollment target

NCT00539240 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 236 participants.

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The verdict

NCT00539240, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 2
Development phase
236 participants
Enrollment target

Study 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.

Interventions

  • DRUG Rabeprazole 20mg, placebo dinner and bedtime
  • DRUG Rabeprazole 20 mg two times, Placebo at bedtime
  • DRUG Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2006-04
Est. Completion 2011-11
Phase Phase 2

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00539240

The ClinicalTrials.gov registry entry for NCT00539240 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Rabeprazole 20mg, placebo dinner and bedtime is the first listed.

NCT00539240 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00539240 about?

NCT00539240 is a clinical study titled "Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI". 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 ...

What is the current status of trial NCT00539240?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 236 participants. The study started on 2006-04. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00539240?

The interventions under investigation include: Rabeprazole 20mg, placebo dinner and bedtime (DRUG), Rabeprazole 20 mg two times, Placebo at bedtime (DRUG), Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant (DRUG).

Who is sponsoring clinical trial NCT00539240?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.