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Nexium Capsules Clinical Experience Investigation

This study is currently recruiting participants.
Verified June 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01434485
First received: September 14, 2011
Last updated: June 14, 2013
Last verified: June 2013
History of Changes
  Purpose

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"


Condition
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:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 ]

Estimated Enrollment: 3300
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Detailed Description:

Nexium capsules Clinical Experience Investigation

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434485

Contacts
Contact: AstraZeneca Japan Clinical Study Information M.Inoue@astrazeneca.com

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01434485     History of Changes
Other Study ID Numbers: D961HC00010
Study First Received: September 14, 2011
Last Updated: June 14, 2013
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:
Carcinoma, Islet Cell
Duodenal Ulcer
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Stomach Ulcer
Ulcer
Zollinger-Ellison Syndrome
Gastrinoma
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Diseases
 Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders
Stomach Diseases
Pathologic Processes
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013