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The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in pediatric subjects.
The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test positive for H. pylori, they will be given eradication medication and brought back in for a re-test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreathTek UBT | Other | Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pranactin citric solution | Other | All patients were required to drink the pranactic citric solution to diagnose H.pylori. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between POCone and UBiT-IR300. | The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300. Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled "A" "B" "C". Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result. DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight). | Baseline, Post Dose (15 min) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Tested Positive/Negative for H. Pylori | Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement. UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Pediatric Gastroenterology | Miami | Florida | 33155 | United States | ||
| University of Texas School of Public Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Urea Hydrolysis Rate (UHR) | Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300 Same patients will be tested on both the POCone and UBiT-IR300 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
95 evaluable subjects for initial diagnosis- each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.
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| ID | Title | Description |
|---|---|---|
| BG000 | BreathTek UBT | Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Must drink the entire content of test solution and receive initial BreathTek UBT of both the UBiT-IR300 and the POC One |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement Between POCone and UBiT-IR300. | The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300. Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled "A" "B" "C". Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result. DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight). | Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed. | Posted | Number | 95% Confidence Interval | Baseline, Post Dose (15 min) |
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At each visit, each subject received 1 administration of Pranactin Citric (4 oz of solution in water). This was the only component with patient contact. Hence, there is only one arm for adverse events evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pranactin Citric Solution | At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment | Headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tao Wang, PhD | Otsuka America Pharmaceutical, Inc | 240-683-3213 | Tao.Wang@otsuka-us.com |
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| Single Study Visit (1 hour of testing) |
| El Paso |
| Texas |
| 79902 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77054 | United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Number of Participants |
|
|
|
|
|
| Other Pre-specified | Number of Participants Tested Positive/Negative for H. Pylori | Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement. UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori. | 95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one. | Posted | Number | Participants | Single Study Visit (1 hour of testing) |
|
|
|
| 0 |
| 99 |
| 4 |
| 99 |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment | cough |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | Dry Mouth |
|
| Acute Upper Respiratory Infection | Infections and infestations | MedDRA | Non-systematic Assessment | Acute Upper Respiratory Infection |
|
Central/Principal Investigator may publish the results of the study. However, at least 60 days prior to submitting to a publisher or a public presentation, a copy of the manuscript will be provided to the Sponsor for review. PI understands and agrees that as such, participation in the study involves a commitment to publish the data from the study in a cooperative publication prior to publication or oral presentation of efficacy/safety results on an individual basis.