Trial Outcomes & Findings for POCone-UBiT-IR300 Pediatric Comparison Study (NCT NCT01623154)
NCT ID: NCT01623154
Last Updated: 2015-02-23
Results Overview
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).
COMPLETED
PHASE4
99 participants
Baseline, Post Dose (15 min)
2015-02-23
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
99
|
|
Overall Study
Available for Analysis
|
95
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Did not drink Pranactin Citric
|
4
|
Baseline Characteristics
POCone-UBiT-IR300 Pediatric Comparison Study
Baseline characteristics by cohort
| Measure |
BreathTek UBT
n=95 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
95 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 Number of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post Dose (15 min)Population: 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.
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).
Outcome measures
| Measure |
Urea Hydrolysis Rate (UHR) Values
n=95 Participants
Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
|
POCone
This is the device being tested and compared to the FDA approved device.
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|---|---|---|
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Agreement Between POCone and UBiT-IR300.
Deming Regression Analysis
|
0.990 (NUMBER)
Interval 0.987 to 0.993
|
—
|
|
Agreement Between POCone and UBiT-IR300.
Passing-Bablok Regression Analysis
|
0.995 (NUMBER)
Interval 0.99 to 1.0
|
—
|
|
Agreement Between POCone and UBiT-IR300.
Regular Regression Analysis
|
0.990 (NUMBER)
Interval 0.987 to 0.993
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single Study Visit (1 hour of testing)Population: 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.
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.
Outcome measures
| Measure |
Urea Hydrolysis Rate (UHR) Values
n=95 Participants
Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
|
POCone
n=95 Participants
This is the device being tested and compared to the FDA approved device.
|
|---|---|---|
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Number of Participants Tested Positive/Negative for H. Pylori
Positive for H.pylori
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24 Participants
|
24 Participants
|
|
Number of Participants Tested Positive/Negative for H. Pylori
Negative for H. pylori
|
71 Participants
|
71 Participants
|
Adverse Events
Pranactin Citric Solution
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pranactin Citric Solution
n=99 participants at risk
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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|---|---|
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Nervous system disorders
Headache
|
2.0%
2/99 • Number of events 2
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.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.0%
1/99 • Number of events 1
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.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.0%
1/99 • Number of events 1
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.
|
|
Infections and infestations
Acute Upper Respiratory Infection
|
1.0%
1/99 • Number of events 1
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER