CompletedNCT01623154Updated Feb 23, 2015Results posted

POCone-UBiT-IR300 Pediatric Comparison Study

A Phase 4 interventional study of Pranactin citric solution in Bacterial Infection Due to Helicobacter Pylori (H. Pylori), sponsored by Otsuka America Pharmaceutical. Completed at 3 sites in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-02-23.

Sponsored by Otsuka America Pharmaceutical (part of Otsuka Holdings Co., Ltd.) · Phase 4, Interventional, and Diagnostic

Phase: Phase 4
Study type: Interventional
Enrollment: 99
Allocation: Not applicable
Ages: 3 Years to 18 Years
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Keywords

Helicobacter pylori

In context

Lead sponsor

Otsuka America Pharmaceutical is the lead sponsor of 10 studies on the registry; none are open to participants now.

Browse Otsuka America Pharmaceutical studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female subject ages 3 to 1711/12 years.
Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.)
Subject and/or parent/legal guardian is capable of giving assent or consent.
Subject is able to complete the urea breath test by investigator's assessment.

Exclusion criteria

Exclusion Criteria:

Subject is hypersensitive to mannitol, citric acid and/or aspartame.
Previous diagnosis of phenylketonuria (PKU.
Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions.
Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples.
Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.)
Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing.
Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing.
Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing.
Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing.
Treatment for eradication of H pylori within 28 days before testing or retesting.
Participation in a drug or device study within 30 days of testing

Study design

Phase: Phase 4
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 99 participants (actual)

Study arms

Other
BreathTek UBT
Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300
Other: Pranactin citric solution

Interventions

OtherPranactin citric solution
All patients were required to drink the pranactic citric solution to diagnose H.pylori.

What researchers measure

Primary outcomes

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).
Time frame: Baseline, Post Dose (15 min)

Other outcomes

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.
Time frame: Single Study Visit (1 hour of testing)

Results

Posted Jan 13, 2015

Participant flow

Participant flow — Overall Study
Milestone	Urea Hydrolysis Rate (UHR)
Started	99
Available for analysis	95
Completed	95
Not completed	4
Withdrew: Did not drink pranactin citric	4

Outcome measures

PrimaryAgreement 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).

Time frame:: Baseline, Post Dose (15 min)
Reported as:: Number

Agreement Between POCone and UBiT-IR300.
Measure	Urea Hydrolysis Rate (UHR) Values
Deming Regression Analysis	0.990 (0.987 to 0.993)
Passing-Bablok Regression Analysis	0.995 (0.990 to 1.00)
Regular Regression Analysis	0.990 (0.987 to 0.993)

Statistical analysis

Urea Hydrolysis Rate (UHR) Values · Deming Regression · Slope: 0.99 · 95% CI 0.987 to 0.99395% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Deming Regression · Intercept: -.04 · 95% CI -0.25 to 0.1795% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Regression, Linear · Slope: 0.990 · 95% CI 0.987 to 0.99395% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Regression, Linear · Intercept: -0.03 · 95% CI -0.24 to 0.1895% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Passing-Bablock · Slope: 0.995 · 95% CI 0.990 to 1.00095% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Passing-Bablok · Intercept: -0.04 · 95% CI -0.30 to 0.0195% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Relative sensitivity, %: 100 · 95% CI 85.8 to 10095% confidence interval is used instead of p-value.
Urea Hydrolysis Rate (UHR) Values · Relative specificity, %: 100 · 95% CI 94.9 to 10095% confidence interval is used instead of p-value.

Other pre-specifiedNumber 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.

Time frame:: Single Study Visit (1 hour of testing)
Reported as:: Number · Participants

Number of Participants Tested Positive/Negative for H. Pylori
Participants	UBiT-IR300	POCone
Positive for H.pylori	24	24
Negative for H. pylori	71	71

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pranactin Citric Solution	—	0/99 (0%)	4/99 (4%)

Most frequent other events

Most frequent other events
Event	Pranactin Citric Solution
HeadacheNervous system disorders	2/99
coughRespiratory, thoracic and mediastinal disorders	1/99
Dry MouthGastrointestinal disorders	1/99
Acute Upper Respiratory InfectionInfections and infestations	1/99

Baseline characteristics

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.

Age, Categorical
Age, Categorical(Participants)	BreathTek UBT
<=18 years	95
Between 18 and 65 years	0
>=65 years	0

Age, Continuous
Age, Continuous(years)	BreathTek UBT
Mean	10.5 (3.4 to 18.0)

Sex: Female, Male
Sex: Female, Male(Participants)	BreathTek UBT
Female	54
Male	41

Region of Enrollment
Region of Enrollment(Number of Participants)	BreathTek UBT
United States	95

Study locations

3 sites

Miami Pediatric Gastroenterology
Miami, Florida 33155, United States
University of Texas School of Public Health
El Paso, Texas 79902, United States
Baylor College of Medicine
Houston, Texas 77054, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Mar 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2015, 1 year 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 15, 2012
First posted: Jun 19, 2012
Start: Jul 2012
Primary completionActual: Mar 2013
CompletionActual: Apr 2013
Results first posted: Jan 13, 2015
Last update: Feb 23, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01623154
Lead sponsor: Otsuka America Pharmaceutical
Responsible party: Sponsor
First posted: Jun 19, 2012
Start date: Jul 2012
Primary completion: Mar 2013
Completion: Apr 2013
Results posted: Jan 13, 2015
Last update: Feb 23, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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