Trial · NCT00825630
13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
NCT00825630, Phase 4, Completed, Meridian Bioscience, Inc.; results first posted 2011-10-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors). Trials, record NCT00825630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00825630
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)
- NCT number
- NCT00825630
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 123 participants, actual
- Lead sponsor
- Meridian Bioscience, Inc.
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Lansoprazole (Lanton), Omeprezole (Losec), Pantoprazole(Controloc), Esomeprazole (Nexium)
- First posted
- 2009-01-21
- Last updated
- 2022-12-20
- Results first posted
- 2011-10-07
- Limitations and caveats
- It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | 17 days | Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB\>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB\<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has \> 96% accuracy. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | 17 days | Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Lansoprazole (Lanton) | False negatives (DOB<5) after 3 days of no PPI | 1 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Omeprazole( Losec) | False negatives (DOB<5) after 3 days of no PPI | 3 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Pantoprazole (Controloc) | False negatives (DOB<5) after 3 days of no PPI | 1 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Esomeprazole (Nexium) | False negatives (DOB<5) after 3 days of no PPI | 0 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Lansoprazole (Lanton) | False negatives (DOB<5) after 1 day of no PPI | 2 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Omeprazole( Losec) | False negatives (DOB<5) after 1 day of no PPI | 4 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Pantoprazole (Controloc) | False negatives (DOB<5) after 1 day of no PPI | 2 | participants | |
| Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. | Esomeprazole (Nexium) | False negatives (DOB<5) after 1 day of no PPI | 1 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lansoprazole (Lanton) | 29 | |
| Overall Study | STARTED | Omeprazole( Losec) | 62 | |
| Overall Study | STARTED | Pantoprazole (Controloc) | 19 | |
| Overall Study | STARTED | Esomeprazole (Nexium) | 13 | |
| Overall Study | COMPLETED | Lansoprazole (Lanton) | 29 | |
| Overall Study | COMPLETED | Omeprazole( Losec) | 62 | |
| Overall Study | COMPLETED | Pantoprazole (Controloc) | 19 | |
| Overall Study | COMPLETED | Esomeprazole (Nexium) | 13 | |
| Overall Study | NOT COMPLETED | Lansoprazole (Lanton) | 0 | |
| Overall Study | NOT COMPLETED | Omeprazole( Losec) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lansoprazole (Lanton) | ||
| Total, all-cause mortality | Omeprazole( Losec) | ||
| Total, all-cause mortality | Pantoprazole (Controloc) | ||
| Total, all-cause mortality | Esomeprazole (Nexium) | ||
| Total, other adverse events | Lansoprazole (Lanton) | 0 | 29 |
| Total, other adverse events | Omeprazole( Losec) | 0 | 62 |
| Total, other adverse events | Pantoprazole (Controloc) | 0 | 19 |
| Total, other adverse events | Esomeprazole (Nexium) | 0 | 13 |
| Total, serious adverse events | Lansoprazole (Lanton) | 0 | 29 |
| Total, serious adverse events | Omeprazole( Losec) | 0 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12526935 | RESULT |
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/NCT00825630
GET https://conductscience.org/api/trials/v1/NCT00825630/registered