Who is sponsoring NCT02528721?

NCT02528721 is sponsored by Meridian Bioscience, Inc..

What drugs are being tested in NCT02528721?

Interventions in NCT02528721: Dual Mode BreathID Hp System.

What condition does NCT02528721 study?

NCT02528721 studies Helicobacter Pylori Infection.

Is NCT02528721 still recruiting?

NCT02528721 is currently completed. Last updated 19 December 2022.

Are results published for NCT02528721?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-12-19 · How we verify

NCT02528721

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Validation Study to Evaluate Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp Lab System Compared to Biopsy Results

Completed Phase 3 Results posted Last updated 19 December 2022

What this trial tests

Phase 3 trial testing Dual Mode BreathID Hp System in Helicobacter Pylori Infection in 282 participants. Completed in 1 July 2016.

Timeline

1 October 2015

Primary endpoint
1 June 2016

1 July 2016

Quick facts

Lead sponsor	Meridian Bioscience, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	282
Start date	1 October 2015
Primary completion	1 June 2016
Estimated completion	1 July 2016
Sites	13 locations across United States, Israel

Drugs / interventions tested

Dual Mode BreathID Hp System

Conditions studied

Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →

Sponsor

Meridian Bioscience, Inc. — full company profile →

Who can join

18 and older, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Time frame: 9 months
Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result

Sponsor's own description

The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The validity of breath collection bags method in detecting Helicobacter pylori using the novel BreathID ® Hp Lab System: a multicenter clinical study in 257 subjects.
Richter V, Gonzalez JO, Hazan S, Gottlieb G, et al · · 2019 · cited 5× · PMID 31192315 · DOI 10.1177/2631774519843401

Verify or expand the search:

Other recruiting trials for Helicobacter Pylori Infection

Currently open trials in the same condition.

NCT07285096 — P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication · recruiting
NCT07358130 — Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy · NA · recruiting
NCT07165444 — Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatme · NA · recruiting
NCT06929962 — VA Dual Sequential Therapy · Phase 4 · recruiting
NCT06959368 — Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication · Phase 4 · recruiting

Other Meridian Bioscience, Inc. trials

Trials by the same sponsor.

NCT05681156 — Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol · completed
NCT03680898 — Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Ge · NA · unknown
NCT03611101 — Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials · completed
NCT03422341 — Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs. · NA · completed
NCT03251261 — Detection of Cytomegalovirus Virus in Neonates · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02528721 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Meridian Bioscience, Inc.
Last refreshed: 19 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02528721.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing