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POCone-UBiT-IR300 Pediatric Comparison Study

NCT01623154 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-02-23

Study results available
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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.

Conditions

  • Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Interventions

OTHER

Pranactin citric solution

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

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623154 on ClinicalTrials.gov