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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR NEXIUM IV


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505(b)(2) Clinical Trials for Nexium Iv

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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn AstraZeneca Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗ Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs Withdrawn Medstar Health Research Institute Phase 4 2006-12-01 The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

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.
NCT00123656 ↗ Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis Completed University of Utah 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.
NCT00170001 ↗ Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy Completed AstraZeneca N/A 2005-04-01 The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.
NCT00170001 ↗ Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy Completed Mayo Clinic N/A 2005-04-01 The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nexium Iv

Condition Name

Condition Name for Nexium Iv
Intervention Trials
GERD 16
Gastroesophageal Reflux Disease 15
Healthy 14
Helicobacter Pylori Infection 11
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Condition MeSH

Condition MeSH for Nexium Iv
Intervention Trials
Gastroesophageal Reflux 47
Esophagitis, Peptic 18
Esophagitis 13
Dyspepsia 13
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Clinical Trial Locations for Nexium Iv

Trials by Country

Trials by Country for Nexium Iv
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 Iv
Location Trials
California 11
Texas 11
Florida 8
Pennsylvania 8
New York 8
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Clinical Trial Progress for Nexium Iv

Clinical Trial Phase

Clinical Trial Phase for Nexium Iv
Clinical Trial Phase Trials
Phase 4 59
Phase 3 33
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Nexium Iv
Clinical Trial Phase Trials
Completed 118
Unknown status 14
Terminated 8
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Clinical Trial Sponsors for Nexium Iv

Sponsor Name

Sponsor Name for Nexium Iv
Sponsor Trials
AstraZeneca 65
Chinese University of Hong Kong 4
CJ HealthCare Corporation 4
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Sponsor Type

Sponsor Type for Nexium Iv
Sponsor Trials
Industry 114
Other 101
U.S. Fed 4
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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Moodys
Merck
Mallinckrodt
Boehringer Ingelheim

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