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Trial record 9 of 49 for:    "Zollinger-Ellison Syndrome"

Nexium Capsules Clinical Experience Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01434485
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison Syndrome

Detailed Description:
Nexium capsules Clinical Experience Investigation

Study Design

Study Type : Observational
Actual Enrollment : 3691 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexium Capsules Clinical Experience Investigation
Study Start Date : September 2011
Primary Completion Date : March 2014
Study Completion Date : March 2014


Groups and Cohorts

Group/Cohort
Nexium


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434485


Locations
Japan
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
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
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
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
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
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD AstraZeneca K.K.
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01434485     History of Changes
Other Study ID Numbers: D961HC00010
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 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:
Zollinger-Ellison Syndrome
Gastrinoma
Ulcer
Esophagitis
Stomach Ulcer
Duodenal Ulcer
Esophagitis, Peptic
Gastroesophageal Reflux
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms