Trial · NCT01265550
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
NCT01265550, Phase 3, Completed, VA Office of Research and Development; results first posted 2018-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors. Trials, record NCT01265550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01265550
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
- NCT number
- NCT01265550
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 366 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- GERD
- Interventions
- Nissen fundoplication, baclofen, Desipramine
- First posted
- 2010-12-23
- Last updated
- 2020-01-22
- Results first posted
- 2018-02-26
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months | 12 months | Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months. Failure; \<50% improvement in the baseline GERD-HRQL score at 12 months or: 1. For patients randomized to Surgical Treatment: a.\<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit. 2. For patients randomized to Active Medical or Placebo Medical Treatment: a.inability to tolerate both study medications or b.For patients treated with desipramine, i.\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit. |
| Secondary | Number of Enrolled Participants With Esophageal Ulceration. | Screening | |
| Secondary | Number of Enrolled Participants With Reflux Esophagus. | Screening | |
| Secondary | Number of Enrolled Participants With Eosinophilic Esophagitis | Screening | |
| Secondary | Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum. | Screening | |
| Secondary | Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum | Screening | |
| Secondary | Number of Enrolled Participants With Candida Esophagitis. | Screening | |
| Secondary | Number of Enrolled Participants With Gastric Outlet Obstruction | Screening | |
| Secondary | Number of Enrolled Participants With Achalasia | Screening | |
| Secondary | Number of Enrolled Participants With Aperistalsis | Screening |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 registered outcomesOutcomes54
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Enrolled Participants With Esophageal Ulceration. | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for esophageal ulceration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Reflux Esophagus. | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for reflux esophagus. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Eosinophilic Esophagitis | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for eosinophilic esophagitis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum. | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for active ulcerations of the stomach and/or duodenum | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for neoplasm of the esophagus, stomach or duodenum | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Candida Esophagitis. | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for candida esophagitis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Gastric Outlet Obstruction | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for gastric outlet obstruction | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Achalasia | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for achalasia | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Enrolled Participants With Aperistalsis | Screening | The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for aperistalsis | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months | Medical Treatment Group | 7 | Participants | ||
| Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months | Surgical Treatment Group | 18 | Participants | ||
| Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months | Placebo Medical Treatment Group | 3 | Participants | ||
| Number of Enrolled Participants With Esophageal Ulceration. | All Enrolled | 0 | Participants | ||
| Number of Enrolled Participants With Reflux Esophagus. | All Enrolled | 4 | Participants | ||
| Number of Enrolled Participants With Eosinophilic Esophagitis | All Enrolled | 16 | Participants | ||
| Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum. | All Enrolled | 3 | Participants | ||
| Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum | All Enrolled | 0 | Participants | ||
| Number of Enrolled Participants With Candida Esophagitis. | All Enrolled | 3 | Participants | ||
| Number of Enrolled Participants With Gastric Outlet Obstruction | All Enrolled | 0 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre Randomization | STARTED | Medical Treatment Group | 0 | |
| Pre Randomization | STARTED | Surgical Treatment Group | 0 | |
| Pre Randomization | STARTED | Placebo Medical Treatment Group | 0 | |
| Pre Randomization | STARTED | All Enrolled | 366 | |
| Pre Randomization | COMPLETED | Medical Treatment Group | 0 | |
| Pre Randomization | COMPLETED | Surgical Treatment Group | 0 | |
| Pre Randomization | COMPLETED | Placebo Medical Treatment Group | 0 | |
| Pre Randomization | COMPLETED | All Enrolled | 78 | |
| Pre Randomization | NOT COMPLETED | Medical Treatment Group | 0 | |
| Pre Randomization | NOT COMPLETED | Surgical Treatment Group | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events636
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Medical Treatment Group | 3 | 25 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Surgical Treatment Group | 1 | 27 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Medical Treatment Group | 1 | 26 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | All Enrolled | 9 | 366 | 9 |
| other | Dyspepsia | Gastrointestinal disorders | Medical Treatment Group | 2 | 25 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Surgical Treatment Group | 1 | 27 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo Medical Treatment Group | 2 | 26 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | All Enrolled | 8 | 366 | 8 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Medical Treatment Group | 1 | 25 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Surgical Treatment Group | 0 | 27 | 0 |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medical Treatment Group | 0 | 25 |
| Total, all-cause mortality | Surgical Treatment Group | 0 | 27 |
| Total, all-cause mortality | Placebo Medical Treatment Group | 0 | 26 |
| Total, all-cause mortality | All Enrolled | 0 | 288 |
| Total, other adverse events | Medical Treatment Group | 18 | 25 |
| Total, other adverse events | Surgical Treatment Group | 17 | 27 |
| Total, other adverse events | Placebo Medical Treatment Group | 18 | 26 |
| Total, other adverse events | All Enrolled | 79 | 366 |
| Total, serious adverse events | Medical Treatment Group | 4 | 25 |
| Total, serious adverse events | Surgical Treatment Group | 4 | 27 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31618539 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01265550
GET https://conductscience.org/api/trials/v1/NCT01265550/registered?page=2