At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 99 enrolled
Drug / intervention
Pranactin citric solutionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Pranactin citric solution for Bacterial Infection Due to Helicobacter Pylori (H. Pylori). Completed, enrolled 99 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionMar 2013
Study CompletionApr 2013
TodayJul 2026
First PostedJun 19, 2012
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.0 years ago
Interventions
Pranactin citric solutionother
All patients were required to drink the pranactic citric solution to diagnose H.pylori.