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. |
| NCT00669955 ↗ | Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy | Completed | Forest Laboratories | 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| NCT00712413 ↗ | Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori | Withdrawn | Axcan Pharma | Phase 3 | 2008-08-01 | The purpose of this study is to evaluate the effect of Pylera when given twice a day.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. |
| NCT00712413 ↗ | Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori | Withdrawn | Forest Laboratories | Phase 3 | 2008-08-01 | The purpose of this study is to evaluate the effect of Pylera when given twice a day.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 | >Sponsor | >Phase | >Start Date | >Summary |
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