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NCT01623154 · ClinicalTrials.gov registry record · Phase 4
POCone-UBiT-IR300 Pediatric Comparison Study
A Phase 4 study, sponsored by Otsuka America Pharmaceutical.
- Completed
- Registry status
- Phase 4
- Development phase
- 99
- Enrollment target
NCT01623154: Completed Phase 4 study, sponsored by Otsuka America Pharmaceutical.
NCT01623154 is a Phase 4 study that has completed, run by Otsuka America Pharmaceutical. The registered enrollment target is 99 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623154, a Phase 4 study, has completed, sponsored by Otsuka America Pharmaceutical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 99 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- OTHER Pranactin citric solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT01623154 record still lists
NCT01623154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Pranactin citric solution is the first listed.
NCT01623154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01623154 about?
NCT01623154 is a clinical study titled "POCone-UBiT-IR300 Pediatric Comparison Study". 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.
What is the current status of trial NCT01623154?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 99 participants. The study started on 2012-07. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01623154?
The interventions under investigation include: Pranactin citric solution (OTHER).
Who is sponsoring clinical trial NCT01623154?
This trial is sponsored by Otsuka America Pharmaceutical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01623154's enrollment target sits among peer trials
99 853rd of 2000 higher than 1,147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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