CLINICAL TRIALS PROFILE FOR ESOMEPRAZOLE SODIUM

All Clinical Trials for Esomeprazole Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC	Withdrawn	Eurofarma Laboratorios S.A.	Phase 3	1969-12-31	A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated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.

Clinical Trial Conditions for Esomeprazole Sodium

Condition Name

Condition Name for Esomeprazole Sodium
Intervention	Trials
Gastroesophageal Reflux Disease	2
Healthy Volunteers	2
Atrial Fibrillation	1
Gastric Ulcer	1

Condition MeSH

Condition MeSH for Esomeprazole Sodium
Intervention	Trials
Gastroesophageal Reflux	3
Esophagitis, Peptic	2
Dyssomnias	1
Atrial Fibrillation	1

Clinical Trial Locations for Esomeprazole Sodium

Trials by Country

Trials by Country for Esomeprazole Sodium
Location	Trials
Brazil	6
United States	5
China	2
Australia	1
Taiwan	1

Trials by US State

Trials by US State for Esomeprazole Sodium
Location	Trials
Missouri	1
Tennessee	1
Pennsylvania	1
Louisiana	1
Delaware	1

Clinical Trial Progress for Esomeprazole Sodium

Clinical Trial Phase

Clinical Trial Phase for Esomeprazole Sodium
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Esomeprazole Sodium
Clinical Trial Phase	Trials
Completed	6
Withdrawn	1
Unknown status	1

Clinical Trial Sponsors for Esomeprazole Sodium

Sponsor Name

Sponsor Name for Esomeprazole Sodium
Sponsor	Trials
Janssen-Cilag Pty Ltd	1
Eurofarma Laboratorios S.A.	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1

Sponsor Type

Sponsor Type for Esomeprazole Sodium
Sponsor	Trials
Industry	6
Other	4
U.S. Fed	1