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NCT01265550 · ClinicalTrials.gov registry record · Phase 3
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT01265550: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT01265550 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 366 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01265550, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in approximately one-half of patients. For those patients, an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring. Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and
Interventions
- DRUG Desipramine
- DRUG baclofen
- DEVICE Nissen fundoplication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2012-08-13 |
| Est. Completion | 2016-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01265550
The ClinicalTrials.gov registry entry for NCT01265550 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Desipramine is the first listed.
NCT01265550 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01265550 about?
NCT01265550 is a clinical study titled "A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors". Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $17...
What is the current status of trial NCT01265550?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2012-08-13. Estimated completion is 2016-12-30.
What interventions are being tested in trial NCT01265550?
The interventions under investigation include: Desipramine (DRUG), baclofen (DRUG), Nissen fundoplication (DEVICE).
Who is sponsoring clinical trial NCT01265550?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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