Trials / Completed
CompletedNCT01623154
POCone-UBiT-IR300 Pediatric Comparison Study
A Prospective, Multi-Center, Open-Label Study to Compare the POCone® With the UBiT®-IR300 in Measurement of 13CO2/12CO2 Ratio in Breath Samples Collected From Pediatric Subjects Ages 3 to 17 Years With Upper Gastrointestinal Signs and Symptoms
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- Otsuka America Pharmaceutical · Industry
- Sex
- All
- Age
- 3 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Pranactin citric solution | All patients were required to drink the pranactic citric solution to diagnose H.pylori. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2013-03-01
- Completion
- 2013-04-01
- First posted
- 2012-06-19
- Last updated
- 2015-02-23
- Results posted
- 2015-01-13
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01623154. Inclusion in this directory is not an endorsement.