PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
Recruiting
Phase 3
Interventional Study
Helicobacter Pylori
Safety
Efficacy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 40 (estimated)
- Sponsor
- ARJ Medical, Inc. · Industry
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About This Trial
This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.
Centers will …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female age 3-17 at the time of visit
* Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
* Naive to H. pylori treatment in the past 4 weeks
Exclusion Criteria:
* Pregnant and/or lactating women
* Presence of a cond…
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