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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR ESOMEPRAZOLE MAGNESIUM


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505(b)(2) Clinical Trials for Esomeprazole Magnesium

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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 Esomeprazole Magnesium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00206024 ↗ Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Completed AstraZeneca Phase 4 2004-11-01 This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
NCT00206180 ↗ NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Completed AstraZeneca Phase 4 2004-06-01 The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.
NCT00206440 ↗ Nexium Study To Suppress Nausea During Chemotherapy Terminated AstraZeneca Phase 3 2005-08-01 This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00206440 ↗ Nexium Study To Suppress Nausea During Chemotherapy Terminated Baylor Breast Care Center Phase 3 2005-08-01 This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.
NCT00317044 ↗ Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma Completed AstraZeneca Phase 2 2006-04-01 The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Esomeprazole Magnesium

Condition Name

Condition Name for Esomeprazole Magnesium
Intervention Trials
GERD 3
Heartburn 2
Erosive Esophagitis 2
Gastroesophageal Reflux Disease 2
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Condition MeSH

Condition MeSH for Esomeprazole Magnesium
Intervention Trials
Gastroesophageal Reflux 5
Esophagitis 3
Barrett Esophagus 2
Heartburn 2
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Clinical Trial Locations for Esomeprazole Magnesium

Trials by Country

Trials by Country for Esomeprazole Magnesium
Location Trials
United States 62
Italy 9
Canada 5
Argentina 4
Mexico 4
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Trials by US State

Trials by US State for Esomeprazole Magnesium
Location Trials
Texas 4
California 4
Florida 3
Pennsylvania 3
North Carolina 3
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Clinical Trial Progress for Esomeprazole Magnesium

Clinical Trial Phase

Clinical Trial Phase for Esomeprazole Magnesium
Clinical Trial Phase Trials
Phase 4 6
Phase 3 5
Phase 2 3
[disabled in preview] 4
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Clinical Trial Status

Clinical Trial Status for Esomeprazole Magnesium
Clinical Trial Phase Trials
Completed 14
Withdrawn 2
Active, not recruiting 1
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Clinical Trial Sponsors for Esomeprazole Magnesium

Sponsor Name

Sponsor Name for Esomeprazole Magnesium
Sponsor Trials
AstraZeneca 11
Torrent Pharmaceuticals Limited 2
Baylor Breast Care Center 1
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Sponsor Type

Sponsor Type for Esomeprazole Magnesium
Sponsor Trials
Industry 14
Other 5
NIH 1
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