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Last Updated: December 6, 2019

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CLINICAL TRIALS PROFILE FOR NEXIUM

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505(b)(2) Clinical Trials for NEXIUM

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
OTC NCT00443963 Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs Terminated AstraZeneca Phase 4 2006-12-01 We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Patients (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible individuals will undergo biopsies of antrum and corpus. The subjects will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC NCT00443963 Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-Steroidal Anti-Inflammatory Drugs Terminated Medstar Health Research Institute Phase 4 2006-12-01 We hypothesize that patients receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Patients (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible individuals will undergo biopsies of antrum and corpus. The subjects will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all patients will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for NEXIUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00069823 Study of Acid Reflux in Asthma Completed American Lung Association Asthma Clinical Research Centers Phase 3 2003-09-01 The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 Study of Acid Reflux in Asthma Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2003-09-01 The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 Study of Acid Reflux in Asthma Completed Johns Hopkins Bloomberg School of Public Health Phase 3 2003-09-01 The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00123656 Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis Completed American Society for Gastrointestinal Endoscopy Phase 2 2004-08-01 Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NEXIUM

Condition Name

Condition Name for NEXIUM
Intervention Trials
GERD 16
Gastroesophageal Reflux Disease 12
Healthy 12
Gastroesophageal Reflux 7
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Condition MeSH

Condition MeSH for NEXIUM
Intervention Trials
Gastroesophageal Reflux 38
Esophagitis 12
Ulcer 12
Dyspepsia 10
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Clinical Trial Locations for NEXIUM

Trials by Country

Trials by Country for NEXIUM
Location Trials
United States 158
Japan 57
Canada 41
Italy 29
Germany 24
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Trials by US State

Trials by US State for NEXIUM
Location Trials
California 11
Texas 11
Pennsylvania 8
New York 8
North Carolina 7
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Clinical Trial Progress for NEXIUM

Clinical Trial Phase

Clinical Trial Phase for NEXIUM
Clinical Trial Phase Trials
Phase 4 51
Phase 3 31
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for NEXIUM
Clinical Trial Phase Trials
Completed 91
Not yet recruiting 11
Recruiting 10
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Clinical Trial Sponsors for NEXIUM

Sponsor Name

Sponsor Name for NEXIUM
Sponsor Trials
AstraZeneca 60
Chinese University of Hong Kong 4
CJ HealthCare Corporation 4
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Sponsor Type

Sponsor Type for NEXIUM
Sponsor Trials
Industry 98
Other 73
U.S. Fed 4
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