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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

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505(b)(2) Clinical Trials for Amoxicillin; Clarithromycin; Omeprazole

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 Amoxicillin; Clarithromycin; Omeprazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002682 Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach Completed National Cancer Institute (NCI) Phase 2 1995-08-01 RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach Completed M.D. Anderson Cancer Center Phase 2 1995-08-01 RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151 Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma Completed University of Glasgow Phase 2 1997-09-01 RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003151 Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 1997-09-01 RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00149084 Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori Unknown status Yokoyama Foundation for Clinical Pharmacology Phase 3 2003-04-01 The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.
NCT00149084 Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori Unknown status Hamamatsu University Phase 3 2003-04-01 The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.
NCT00206440 Nexium Study To Suppress Nausea During Chemotherapy Terminated AstraZeneca Phase 3 2005-08-01 This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amoxicillin; Clarithromycin; Omeprazole

Condition Name

Condition Name for Amoxicillin; Clarithromycin; Omeprazole
Intervention Trials
Helicobacter Pylori Infection 11
Non-alcoholic Fatty Liver Disease 3
Helicobacter Infections 3
Gastritis 2
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Condition MeSH

Condition MeSH for Amoxicillin; Clarithromycin; Omeprazole
Intervention Trials
Helicobacter Infections 13
Communicable Diseases 6
Infection 6
Gastritis 5
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Clinical Trial Locations for Amoxicillin; Clarithromycin; Omeprazole

Trials by Country

Trials by Country for Amoxicillin; Clarithromycin; Omeprazole
Location Trials
United States 5
Spain 4
Iran, Islamic Republic of 4
United Kingdom 3
Pakistan 2
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Trials by US State

Trials by US State for Amoxicillin; Clarithromycin; Omeprazole
Location Trials
Texas 3
Missouri 1
Florida 1
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Clinical Trial Progress for Amoxicillin; Clarithromycin; Omeprazole

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin; Clarithromycin; Omeprazole
Clinical Trial Phase Trials
Phase 4 11
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Amoxicillin; Clarithromycin; Omeprazole
Clinical Trial Phase Trials
Completed 21
Unknown status 4
Not yet recruiting 3
[disabled in preview] 5
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Clinical Trial Sponsors for Amoxicillin; Clarithromycin; Omeprazole

Sponsor Name

Sponsor Name for Amoxicillin; Clarithromycin; Omeprazole
Sponsor Trials
Tehran University of Medical Sciences 4
Axcan Pharma 1
Yokoyama Foundation for Clinical Pharmacology 1
[disabled in preview] 4
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Sponsor Type

Sponsor Type for Amoxicillin; Clarithromycin; Omeprazole
Sponsor Trials
Other 45
Industry 5
NIH 1
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