CLINICAL TRIALS PROFILE FOR PYLORI-CHEK BREATH TEST

505(b)(2) Clinical Trials for PYLORI-CHEK BREATH TEST

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

All Clinical Trials for PYLORI-CHEK BREATH TEST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	Apotekerfonden af 1991	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	AstraZeneca	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	Danish College of General Practitioners	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	Research Unit of General Practice, Odense	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	The Danish Medical Research Council	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.
NCT00120315 ↗	Proton Pump Inhibitor Treatment Stop	Completed	University of Southern Denmark	Phase 4	2003-12-01	The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.

Clinical Trial Conditions for PYLORI-CHEK BREATH TEST

Condition Name

Condition Name for PYLORI-CHEK BREATH TEST
Intervention	Trials
Helicobacter Pylori Infection	67
Dyspepsia	9
GASTRITIS	8
Helicobacter Infections	6

Condition MeSH

Condition MeSH for PYLORI-CHEK BREATH TEST
Intervention	Trials
Helicobacter Infections	62
Infections	46
Infection	36
Communicable Diseases	26

Clinical Trial Locations for PYLORI-CHEK BREATH TEST

Trials by Country

Trials by Country for PYLORI-CHEK BREATH TEST
Location	Trials
Taiwan	31
China	30
United States	17
Italy	5
Japan	5

Trials by US State

Trials by US State for PYLORI-CHEK BREATH TEST
Location	Trials
Texas	3
Louisiana	2
Michigan	2
Tennessee	1
Mississippi	1

Clinical Trial Progress for PYLORI-CHEK BREATH TEST

Clinical Trial Phase

Clinical Trial Phase for PYLORI-CHEK BREATH TEST
Clinical Trial Phase	Trials
Phase 4	70
Phase 3	14
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for PYLORI-CHEK BREATH TEST
Clinical Trial Phase	Trials
Completed	60
Recruiting	19
Unknown status	15

Clinical Trial Sponsors for PYLORI-CHEK BREATH TEST

Sponsor Name

Sponsor Name for PYLORI-CHEK BREATH TEST
Sponsor	Trials
National Taiwan University Hospital	13
Xijing Hospital of Digestive Diseases	11
Shandong University	7

Sponsor Type

Sponsor Type for PYLORI-CHEK BREATH TEST
Sponsor	Trials
Other	190
Industry	15
NIH	1