Trial · NCT00539240
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
NCT00539240, Phase 2, Phase 3, Completed, US Department of Veterans Affairs; results first posted 2014-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI. Trials, record NCT00539240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00539240
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
- NCT number
- NCT00539240
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 236 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Rabeprazole 20mg, placebo dinner and bedtime, Rabeprazole 20 mg two times, Placebo at bedtime, Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant
- First posted
- 2007-10-04
- Last updated
- 2014-08-18
- Results first posted
- 2014-08-18
- Limitations and caveats
- Recruitment challenges, including difficulty finding patients who fail PPI but had not already been prescribed doubled dose. Necessitated a no-cost extension to complete recruitment
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Symptom control after 6 weeks of treatment | the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline |
| Primary | Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline | Symptom control after 6 weeks of treatment | the number of days with Symptom Intensity Score \< 3 (better) for nighttime heartburn during week 6 as compared to baseline |
| Primary | Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Symptom control after 6 weeks of treatment | the number of days with Symptom Intensity Score \< 3 (better) for acid regurgitation during week 6 as compared to baseline |
| Secondary | Health Related Quality of Life | end of study | SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Symptom control after 6 weeks of treatment | intention to treat (ITT) | days | MEAN |
| SECONDARY | Health Related Quality of Life | end of study | ITT | units on a scale | MEAN |
| PRIMARY | Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline | Symptom control after 6 weeks of treatment | ITT | days | MEAN |
| PRIMARY | Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Symptom control after 6 weeks of treatment | ITT | days | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Arm 1 | 6.6 | Standard Deviation 0.9 | days | |
| Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Arm 2 | 5.9 | Standard Deviation 2.2 | days | |
| Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Arm 3 | 6.1 | Standard Deviation 1.8 | days | |
| Health Related Quality of Life | Arm 1 | 42.0 | Standard Deviation 10.3 | units on a scale | |
| Health Related Quality of Life | Arm 2 | 37.7 | Standard Deviation 11.0 | units on a scale | |
| Health Related Quality of Life | Arm 3 | 37.7 | Standard Deviation 11.0 | units on a scale | |
| Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline | Arm 1 | 6.6 | Standard Deviation 0.9 | days | |
| Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline | Arm 2 | 5.8 | Standard Deviation 2.0 | days | |
| Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline | Arm 3 | 6.0 | Standard Deviation 1.6 | days | |
| Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better) | Arm 1 | 6.7 | Standard Deviation 0.8 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 59 | |
| Overall Study | STARTED | Arm 2 | 55 | |
| Overall Study | STARTED | Arm 3 | 54 | |
| Overall Study | COMPLETED | Arm 1 | 53 | |
| Overall Study | COMPLETED | Arm 2 | 48 | |
| Overall Study | COMPLETED | Arm 3 | 39 | |
| Overall Study | NOT COMPLETED | Arm 1 | 6 | |
| Overall Study | NOT COMPLETED | Arm 2 | 7 | |
| Overall Study | NOT COMPLETED | Arm 3 | 15 |
Source ClinicalTrials.gov
Adverse events42
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 | Flu like symptoms | General disorders | Arm 1 | 0 | 59 | |
| other | Flu like symptoms | General disorders | Arm 2 | 1 | 55 | |
| other | Flu like symptoms | General disorders | Arm 3 | 0 | 54 | |
| other | skin ulceration | Gastrointestinal disorders | Arm 1 | 1 | 59 | |
| other | skin ulceration | Gastrointestinal disorders | Arm 2 | 0 | 55 | |
| other | skin ulceration | Gastrointestinal disorders | Arm 3 | 0 | 54 | |
| other | Other, Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Arm 1 | 1 | 59 | |
| other | Other, Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Arm 2 | 0 | 55 | |
| other | Other, Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Arm 3 | 0 | 54 | |
| other | Dry mouth | Gastrointestinal disorders | Arm 1 | 0 | 59 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, all-cause mortality | Arm 3 | ||
| Total, other adverse events | Arm 1 | 3 | 59 |
| Total, other adverse events | Arm 2 | 1 | 55 |
| Total, other adverse events | Arm 3 | 10 | 54 |
| Total, serious adverse events | Arm 1 | 0 | 59 |
| Total, serious adverse events | Arm 2 | 0 | 55 |
| Total, serious adverse events | Arm 3 | 0 | 54 |
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/NCT00539240
GET https://conductscience.org/api/trials/v1/NCT00539240/events?page=2