Reflux Esophagitis Phase III Study (Maintenance Treatment)

Condition(s) targeted: Reflux Esophagitis

Intervention: Esomeprazole (Drug); Esomeprazole (Drug); Omeprazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Maotsugu Oyama, MD, PhD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca KK Corporate Communications, Phone: +81 6 6453 8011

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Presence/absence of recurrence of Reflux Esophagitis according to Los Angeles classification.

Secondary outcome: Presence/absence of recurrence of Reflux Esophagitis according to Los Angeles classification.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

AstraZeneca KK Corporate Communications, Phone: +81 6 6453 8011

Research Site, Akita, Japan; Not yet recruiting

Research Site, Fukuoka, Japan; Not yet recruiting

Research Site, Kyoto, Japan; Not yet recruiting

Research Site, Oita, Japan; Not yet recruiting

Research Site, Shizuoka, Japan; Not yet recruiting

Research Site, Tottori, Japan; Not yet recruiting

Research Site, Kashiwa, Chiba, Japan; Not yet recruiting

Research Site, Kisarazu, Chiba, Japan; Not yet recruiting

Research Site, Koriyama, Fukishima, Japan; Not yet recruiting

Research Site, Nihonmatsu, Fukishima, Japan; Not yet recruiting

Research Site, Nishishirakawa, Fukishima, Japan; Recruiting

Research Site, Fukuoika, Fukuoka, Japan; Not yet recruiting

Research Site, Kurume, Fukuoka, Japan; Not yet recruiting

Research Site, Nukaya, Fukuoka, Japan; Not yet recruiting

Research Site, Fukuoka, Fukuolka, Japan; Not yet recruiting

Research Site, Koriyama, Fukushima, Japan; Not yet recruiting

Research Site, Shirakawa, Fukushima, Japan; Not yet recruiting

Research Site, Sugawa, Fukushima, Japan; Not yet recruiting

Research Site, Gifu-shi, Gifu, Japan; Not yet recruiting

Research Site, Maebashi, Gunma, Japan; Not yet recruiting

Research Site, Yasunaka, Gunma, Japan; Recruiting

Research Site, Sapporo, Hokkaido, Japan; Not yet recruiting

Research Site, Hitachi, Ibaraki, Japan; Not yet recruiting

Research Site, Mito, Ibaraki, Japan; Not yet recruiting

Research Site, Tsukuba, Ibaraki, Japan; Not yet recruiting

Research Site, Sakaide, Kagawa, Japan; Recruiting

Research Site, Takamatsu, Kagawa, Japan; Not yet recruiting

Research Site, Fujisawa, Kanagawa, Japan; Not yet recruiting

Research Site, Kawasaki, Kanagawa, Japan; Recruiting

Research Site, Sagamihara, Kanagawa, Japan; Not yet recruiting

Research Site, Yokohama, Kanagawa, Japan; Recruiting

Research Site, Shibata, Myagi, Japan; Not yet recruiting

Research Site, Kiso, Nagano, Japan; Recruiting

Research Site, Matsumoto, Nagano, Japan; Not yet recruiting

Research Site, Fujiidera, Osaka, Japan; Not yet recruiting

Research Site, Toyonaka, Osaka, Japan; Not yet recruiting

Research Site, Ohtawara, Tochigi, Japan; Not yet recruiting

Research Site, Toshima-ku, Tokayo, Japan; Not yet recruiting

Research Site, Adachi, Tokyo, Japan; Not yet recruiting

Research Site, Hachioji, Tokyo, Japan; Not yet recruiting

Research Site, Kiyose, Tokyo, Japan; Not yet recruiting

Research Site, Setagaya, Tokyo, Japan; Recruiting

Research Site, Shinagawa, Tokyo, Japan; Not yet recruiting

Research Site, Shimonoseki, Yamaguchi, Japan; Recruiting

Starting date: January 2008
Ending date: November 2009
Last updated: March 11, 2008