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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: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.
NCT00539240 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 236 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline
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
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00539240 record still lists
NCT00539240 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 3 interventions - of which Rabeprazole 20mg, placebo dinner and bedtime is the first listed.
NCT00539240 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00539240's enrollment target sits among peer trials
236 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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