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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR PYLORI-CHEK BREATH TEST

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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00120315 Proton Pump Inhibitor Treatment Stop Completed Odense University Hospital 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pylori-chek Breath Test

Condition Name

Condition Name for Pylori-chek Breath Test
Intervention Trials
Helicobacter Pylori Infection 42
Helicobacter Infections 6
Gastritis 6
Dyspepsia 5
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Condition MeSH

Condition MeSH for Pylori-chek Breath Test
Intervention Trials
Helicobacter Infections 56
Infection 34
Communicable Diseases 22
Gastritis 14
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Clinical Trial Locations for Pylori-chek Breath Test

Trials by Country

Trials by Country for Pylori-chek Breath Test
Location Trials
Taiwan 28
United States 11
China 9
Italy 5
Japan 5
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Trials by US State

Trials by US State for Pylori-chek Breath Test
Location Trials
Texas 2
North Carolina 1
Nevada 1
Michigan 1
Maryland 1
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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 44
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Pylori-chek Breath Test
Clinical Trial Phase Trials
Completed 34
Recruiting 20
Not yet recruiting 13
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Clinical Trial Sponsors for Pylori-chek Breath Test

Sponsor Name

Sponsor Name for Pylori-chek Breath Test
Sponsor Trials
National Taiwan University Hospital 12
Mackay Memorial Hospital 5
Xijing Hospital of Digestive Diseases 5
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Sponsor Type

Sponsor Type for Pylori-chek Breath Test
Sponsor Trials
Other 130
Industry 8
NIH 1
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