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Nexium Capsules Clinical Experience Investigation

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 14, 2011
Last updated: April 14, 2014
Last verified: April 2014
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed Nexium for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "Zollinger-Ellison syndrome"

Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexium Capsules Clinical Experience Investigation

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Adverse Drug Reactions [ Time Frame: Patients with gastric ulcer, anastomotic ulcer or Zollinger-Ellison syndrome: 8 weeks ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with duodenal ulcer: 6 weeks ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with reflux oesophagitis: 8 weeks ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with non-erosive reflux disease: 4 weeks ]

Enrollment: 3691
Study Start Date: September 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Detailed Description:
Nexium capsules Clinical Experience Investigation

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome.
Inclusion Criteria: - Patients treated with Nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome. Exclusion Criteria: - None
  Contacts and Locations
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Please refer to this study by its identifier: NCT01434485

Research Site
Aichi, Japan
Research Site
Akita, Japan
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Aomori, Japan
Research Site
Chiba, Japan
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Ehime, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Iwate, Japan
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Kagawa, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
Research Site
Mie, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Oita, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
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Shimane, Japan
Research Site
Shizuoka, Japan
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Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
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Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

Responsible Party: AstraZeneca Identifier: NCT01434485     History of Changes
Other Study ID Numbers: D961HC00010
Study First Received: September 14, 2011
Last Updated: April 14, 2014

Keywords provided by AstraZeneca:
gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome, Nexium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Duodenal Ulcer
Esophagitis, Peptic
Stomach Ulcer
Zollinger-Ellison Syndrome
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms processed this record on May 25, 2017