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NCT00251732 · ClinicalTrials.gov registry record · Phase 4
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
A Phase 4 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT00251732: Completed Phase 4 study, sponsored by University of Arizona.
NCT00251732 is a Phase 4 study that has completed, run by University of Arizona. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251732, a Phase 4 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
To measure the outcome after 6 weeks of treatment
Interventions
- DRUG Standard dose (once daily) PPI plus low-dose antidepressant
- DRUG Double dose PPI plus evening placebo
- DRUG Rabeprazole , placebo, placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
What the finished NCT00251732 record still lists
NCT00251732 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard dose (once daily) PPI plus low-dose antidepressant is the first listed.
NCT00251732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00251732 about?
NCT00251732 is a clinical study titled "Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)". 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) ...
What is the current status of trial NCT00251732?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2005-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00251732?
The interventions under investigation include: Standard dose (once daily) PPI plus low-dose antidepressant (DRUG), Double dose PPI plus evening placebo (DRUG), Rabeprazole , placebo, placebo (DRUG).
Who is sponsoring clinical trial NCT00251732?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00251732's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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