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Nexium Capsules RE Maintenance Specific Clinical Experience Investigation

This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01562639
First received: March 22, 2012
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to collect following data in patients given Nexium capsule (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis.


Condition
Repeatedly Recurring Esophagitis
Relapsing Reflux Esophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexium Capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis

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: 6 Month ] [ Designated as safety issue: Yes ]
    Adverse event incidence


Secondary Outcome Measures:
  • Non-recurrence rate of reflux oesophagitis [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2012
Estimated Study Completion Date: September 2013

Detailed Description:

Nexium capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with repeatedly recurring/relapsing reflux oesophagitis who will be given Nexium for the first time as a maintenance therapy.

(Patients who had been given Nexium for the initial treatment for reflux oesophagitis can be enrolled to this investigation).

Criteria

Inclusion Criteria:

  • Patients with repeatedly recurring/relapsing reflux oesophagitis who will be given Nexium for the first time as a maintenance therapy.

Exclusion Criteria:

  • Patients having reflux oesophagitis when Nexium is started (Grade A, Grade B, Grade C or Grade D of Los Angeles Classification (Hoshihara's modification) on endoscopy)
  • Patients having previous history of maintenance therapy for repeatedly recurring/ relapsing reflux oesophagitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562639

Contacts
Contact: Maki Inoue M.Inoue@astrazeneca.com

Locations
Japan
Research Site Recruiting
Aichi, Japan
Research Site Completed
Akita, Japan
Research Site Completed
Aomori, Japan
Research Site Recruiting
Chiba, Japan
Research Site Completed
Ehime, Japan
Research Site Recruiting
Fukui, Japan
Research Site Recruiting
Fukuoka, Japan
Research Site Recruiting
Fukushima, Japan
Research Site Completed
Gifu, Japan
Research Site Completed
Gunma, Japan
Research Site Recruiting
Hiroshima, Japan
Research Site Recruiting
Hokkaido, Japan
Research Site Recruiting
Hyogo, Japan
Research Site Recruiting
Ibaraki, Japan
Research Site Completed
Ishikawa, Japan
Research Site Completed
Iwate, Japan
Research Site Completed
Kagawa, Japan
Research Site Recruiting
Kagoshima, Japan
Research Site Recruiting
Kanagawa, Japan
Research Site Completed
Kochi, Japan
Research Site Recruiting
Kumamoto, Japan
Research Site Completed
Kyoto, Japan
Research Site Recruiting
Mie, Japan
Research Site Recruiting
Miyagi, Japan
Research Site Completed
Miyazaki, Japan
Research Site Completed
Nagano, Japan
Research Site Recruiting
Nara, Japan
Research Site Completed
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 Completed
Shiga, Japan
Research Site Completed
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 Completed
Toyama, Japan
Research Site Completed
Wakayama, Japan
Research Site Recruiting
Yamagata, Japan
Research Site Recruiting
Yamaguchi, Japan
Research Site Completed
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: NCT01562639     History of Changes
Other Study ID Numbers: D961HC00013
Study First Received: March 22, 2012
Last Updated: April 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
maintenance therapy,
repeatedly recurring,
relapsing reflux oesophagitis,
Nexium

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Recurrence
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
 Deglutition Disorders
Disease Attributes
Pathologic Processes
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013