Clinical trial NCT01562639: Nexium Capsules RE Maintenance Specific Clinical Experience Investigation
Official title: Nexium Capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Repeatedly Recurring Esophagitis
Relapsing Reflux Esophagitis
Keywords: maintenance therapy,
repeatedly recurring,
relapsing reflux oesophagitis,
Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 647
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: Number of Adverse Drug Reactions
timeFrame: 6 Month
Secondary outcomes:
measure: Non-recurrence rate of reflux oesophagitis
timeFrame: 6 Month
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: