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Last Updated: August 4, 2021

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CLINICAL TRIALS PROFILE FOR PYLERA

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All Clinical Trials for PYLERA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00669955 ↗ Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy Completed Axcan Pharma Phase 3 2008-06-01 This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
NCT00712413 ↗ Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori Withdrawn Axcan Pharma Phase 3 2008-08-01 The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
NCT01335334 ↗ H. Pylori Eradication Using Pyklear in Adults in El Paso, Texas: a Pilot Study Unknown status The University of Texas Health Science Center, Houston Phase 4 2011-03-01 The proposed open-label one arm before-after clinical trial will assess the efficacy of a 14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas. As part of the study we will obtain specimens for culture of H. pylori in a reference laboratory.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PYLERA

Condition Name

Condition Name for PYLERA
Intervention Trials
Treatment of H. Pylori Infection 1
Helicobacter Pylori Infection Treatment 1
Helicobacter Pylori Infection 1
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Condition MeSH

Condition MeSH for PYLERA
Intervention Trials
Helicobacter Infections 4
Infection 2
Communicable Diseases 1
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Clinical Trial Locations for PYLERA

Trials by Country

Trials by Country for PYLERA
Location Trials
United States 3
Canada 1
Italy 1
United Kingdom 1
Lebanon 1
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Trials by US State

Trials by US State for PYLERA
Location Trials
Texas 1
Wisconsin 1
Michigan 1
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Clinical Trial Progress for PYLERA

Clinical Trial Phase

Clinical Trial Phase for PYLERA
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for PYLERA
Clinical Trial Phase Trials
Withdrawn 2
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for PYLERA

Sponsor Name

Sponsor Name for PYLERA
Sponsor Trials
Axcan Pharma 2
Università degli Studi di Sassari 1
American University of Beirut Medical Center 1
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Sponsor Type

Sponsor Type for PYLERA
Sponsor Trials
Other 3
Industry 2
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Dow
McKesson
Moodys
Express Scripts

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