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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR NEXIUM 24HR


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505(b)(2) Clinical Trials for NEXIUM 24HR

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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. Participants (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 participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants 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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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. Participants (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 participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants 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 24HR

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NEXIUM 24HR

Condition Name

Condition Name for NEXIUM 24HR
Intervention Trials
GERD 16
Gastroesophageal Reflux Disease 15
Healthy 14
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Condition MeSH

Condition MeSH for NEXIUM 24HR
Intervention Trials
Gastroesophageal Reflux 47
Esophagitis, Peptic 18
Dyspepsia 14
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Clinical Trial Locations for NEXIUM 24HR

Trials by Country

Trials by Country for NEXIUM 24HR
Location Trials
United States 163
Japan 57
Canada 41
Italy 29
Germany 24
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Trials by US State

Trials by US State for NEXIUM 24HR
Location Trials
California 11
Texas 11
Florida 8
Pennsylvania 8
New York 8
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Clinical Trial Progress for NEXIUM 24HR

Clinical Trial Phase

Clinical Trial Phase for NEXIUM 24HR
Clinical Trial Phase Trials
Phase 4 61
Phase 3 33
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for NEXIUM 24HR
Clinical Trial Phase Trials
Completed 118
Unknown status 14
Terminated 8
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Clinical Trial Sponsors for NEXIUM 24HR

Sponsor Name

Sponsor Name for NEXIUM 24HR
Sponsor Trials
AstraZeneca 65
Chinese University of Hong Kong 5
Xijing Hospital of Digestive Diseases 5
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Sponsor Type

Sponsor Type for NEXIUM 24HR
Sponsor Trials
Industry 114
Other 105
U.S. Fed 4
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