Clinical trial NCT00634114: Reflux Esophagitis Phase III Study (Maintenance Treatment)
Official title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reflux Esophagitis
Keywords: Reflux Esophagitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 540
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.


Eligibility criteria: Inclusion Criteria:

* Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002)
* Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI

Exclusion Criteria:

* Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
* Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Primary outcomes:
measure: Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
timeFrame: up to 4 weeks
measure: Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Kisarazu
country: Japan
facility: Research Site
state: Chiba
city: Koriyama
country: Japan
facility: Research Site
state: Fukishima
city: Nihonmatsu
country: Japan
facility: Research Site
state: Fukishima
city: Nishishirakawa
country: Japan
facility: Research Site
state: Fukishima
city: Fukuoika
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Nukaya
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka
country: Japan
facility: Research Site
state: Fukuolka
city: Koriyama
country: Japan
facility: Research Site
state: Fukushima
city: Shirakawa
country: Japan
facility: Research Site
state: Fukushima
city: Sugawa
country: Japan
facility: Research Site
state: Fukushima
city: Gifu-shi
country: Japan
facility: Research Site
state: Gifu
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Yasunaka
country: Japan
facility: Research Site
state: Gunma
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Mito
country: Japan
facility: Research Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Research Site
state: Ibaraki
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Fujisawa
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Shibata
country: Japan
facility: Research Site
state: Myagi
city: Kiso
country: Japan
facility: Research Site
state: Nagano
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Fujiidera
country: Japan
facility: Research Site
state: Osaka
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Ohtawara
country: Japan
facility: Research Site
state: Tochigi
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokayo
city: Adachi
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji
country: Japan
facility: Research Site
state: Tokyo
city: Kiyose
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Research Site
state: Tokyo
city: Shimonoseki
country: Japan
facility: Research Site
state: Yamaguchi
city: Akita
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Maotsugu Oyama, MD, PhD
role: STUDY_DIRECTOR
References: