CLINICAL TRIALS PROFILE FOR ESOMEPRAZOLE SODIUM
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All Clinical Trials for esomeprazole sodium
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00428701 ↗ | An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium | Completed | AstraZeneca | Phase 4 | 2006-10-01 | This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting. |
NCT00464308 ↗ | A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg | Completed | Janssen-Cilag Pty Ltd | Phase 4 | 2006-11-01 | The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg. |
NCT01471925 ↗ | Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC | Withdrawn | Eurofarma Laboratorios S.A. | Phase 3 | 1969-12-31 | A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm (total of 188 patients). |
NCT02017197 ↗ | Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil | Completed | Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 | 2014-08-01 | The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks. |
NCT02017197 ↗ | Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil | Completed | Federal University of São Paulo | Phase 4 | 2014-08-01 | The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks. |
NCT02037477 ↗ | Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438) | Completed | Takeda | Phase 3 | 2014-01-01 | The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the CYP2C19 extensive metabolizer (EM) genotype. |
NCT02277886 ↗ | Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances | Unknown status | TTY Biopharm | Phase 4 | 2014-11-01 | Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms, resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label, randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include percentage of patients with relief or complete resolution of nighttime heartburn (or regurgitation), percentage of patients with relief or complete resolution of GERD-related sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation) over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI) questionnaire total score, and change of the percentage of patients with relief of nighttime heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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