Trial · NCT01129778
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
NCT01129778, Not applicable, Terminated, Stanford University; results first posted 2017-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus. Trials, record NCT01129778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01129778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
- NCT number
- NCT01129778
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 27 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux
- Interventions
- Zegerid (proton pump inhibitor), Bravo pH monitoring
- First posted
- 2010-05-25
- Last updated
- 2017-06-06
- Results first posted
- 2017-06-06
- Limitations and caveats
The limitations included the small sample size, a cohort of patients with primarily short-segment BE, and the fact that the study relied on comparison of intraoesophageal pH levels on Ome-NaBic to other PPIs based on historical controls.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time Esophageal pH< 4 | Days 1 and 2 | Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH \<4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique. |
| Secondary | Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | Day 1 after therapy period completion | The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time Esophageal pH< 4 | Days 1 and 2 | Participants who completed all protocol-specified assessments were included in the analysis. | percentage of hours | MEAN |
| SECONDARY | Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | Day 1 after therapy period completion | Participants who completed all protocol-specified assessments were included in the analysis. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Total time pH <4 First Day | 0.4 | Standard Deviation 0.5 | percentage of hours |
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Total time pH <4 Second Day | 0.6 | Standard Deviation 1.8 | percentage of hours |
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Upright time pH <4 First Day | 0.7 | Standard Deviation 0.7 | percentage of hours |
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Upright time pH <4 Second Day | 1 | Standard Deviation 3 | percentage of hours |
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Supine time pH <4 First Day | 0.06 | Standard Deviation 0.1 | percentage of hours |
| Percentage of Time Esophageal pH< 4 | Received Zegerid (Ome-NaBic) | Supine time pH <4 Second Day | 0.05 | Standard Deviation 0.2 | percentage of hours |
| Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | Received Zegerid (Ome-NaBic) | 0.5 | Standard Deviation 1.5 | Units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Received Zegerid (Ome-NaBic) | 22 | |
| Overall Study | COMPLETED | Received Zegerid (Ome-NaBic) | 15 | |
| Overall Study | NOT COMPLETED | Received Zegerid (Ome-NaBic) | 7 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Received Zegerid (Ome-NaBic) | ||
| Total, other adverse events | Received Zegerid (Ome-NaBic) | 0 | 22 |
| Total, serious adverse events | Received Zegerid (Ome-NaBic) | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01129778
GET https://conductscience.org/api/trials/v1/NCT01129778/registered