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 ] [ Designated as safety issue: Yes ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with duodenal ulcer: 6 weeks ] [ Designated as safety issue: Yes ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with reflux oesophagitis: 8 weeks ] [ Designated as safety issue: Yes ]
  • Number of Adverse Drug Reactions [ Time Frame: Patients with non-erosive reflux disease: 4 weeks ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01434485

Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
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
Research Site
Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
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Nagasaki, Japan
Research Site
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
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Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
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
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Duodenal Ulcer
Esophagitis, Peptic
Gastroesophageal Reflux
Stomach Ulcer
Zollinger-Ellison Syndrome
Carcinoma, Islet Cell
Deglutition Disorders
Digestive System Diseases
Digestive System Neoplasms
Duodenal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes processed this record on May 26, 2016