CLINICAL TRIALS PROFILE FOR NEXIUM IV

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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased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↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms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

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.

Clinical Trial Conditions for NEXIUM IV

Condition Name

Condition Name for NEXIUM IV
Intervention	Trials
GERD	16
Healthy	15
Gastroesophageal Reflux Disease	15
Helicobacter Pylori Infection	13

Condition MeSH

Condition MeSH for NEXIUM IV
Intervention	Trials
Gastroesophageal Reflux	47
Esophagitis, Peptic	18
Dyspepsia	14
Helicobacter Infections	13

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

Trials by US State

Trials by US State for NEXIUM IV
Location	Trials
California	11
Texas	11
Pennsylvania	8
New York	8
Florida	8

Clinical Trial Progress for NEXIUM IV

Clinical Trial Phase

Clinical Trial Phase for NEXIUM IV
Clinical Trial Phase	Trials
Phase 4	61
Phase 3	34
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for NEXIUM IV
Clinical Trial Phase	Trials
Completed	118
Unknown status	14
Terminated	8

Clinical Trial Sponsors for NEXIUM IV

Sponsor Name

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

Sponsor Type

Sponsor Type for NEXIUM IV
Sponsor	Trials
Industry	115
Other	106
U.S. Fed	4