Reflux Esophagitis Phase III Study (Initial 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

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 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 and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis

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

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

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

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

Criteria:

Inclusion Criteria:

- Endoscopically verified Reflux Esophagitis classified into Los Angeles classification

Grade A, B, C or D within 1 week before randomisation

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; Recruiting

Research Site, Kyoto, Japan; Recruiting

Research Site, Oita, Japan; Recruiting

Research Site, Shizuoka, Japan; Recruiting

Research Site, Tottori, Japan; Recruiting

Research Site, Kashiwa, Chiba, Japan; Recruiting

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

Research Site, Koriyama, Fukishima, Japan; Recruiting

Research Site, Nihonmatsu, Fukishima, Japan; Recruiting

Research Site, Nishishirakawa, Fukishima, Japan; Recruiting

Research Site, Kurume, Fukuoka, Japan; Recruiting

Research Site, Nukaya, Fukuoka, Japan; Recruiting

Research Site, Shirakawa, Fukushima, Japan; 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; Recruiting

Research Site, Mito, Ibaraki, Japan; Recruiting

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

Research Site, Sakaide, Kagawa, Japan; Recruiting

Research Site, Takamatsu, Kagawa, Japan; Recruiting

Research Site, Fujisawa, Kanagawa, Japan; 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; Recruiting

Research Site, Kiso, Nagano, Japan; Recruiting

Research Site, Matsumoto, Nagano, Japan; Recruiting

Research Site, Fujiidera, Osaka, Japan; Recruiting

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

Research Site, Ohtawara, Tochigi, Japan; Recruiting

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

Research Site, Adachi, Tokyo, Japan; Recruiting

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

Research Site, Kiyose, Tokyo, Japan; Recruiting

Research Site, Setagaya, Tokyo, Japan; Recruiting

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

Research Site, Shimonoseki, Yamaguchi, Japan; Recruiting

Starting date: December 2007
Ending date: May 2009
Last updated: March 11, 2008