Reflux Esophagitis Phase III Study (Maintenance Treatment)

Reflux Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634114
• Other study ID #: D961HC00006
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2008
• Last updated: May 18, 2010
• Start date: January 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Reflux Esophagitis

Intervention

Drug:
• Esomeprazole
10mg once daily oral administration
• Esomeprazole
20mg once daily oral administration
• Omeprazole
10mg once daily oral administration

Locations

Country	Name	City	State
Japan	Research Site	Adachi	Tokyo
Japan	Research Site	Akita
Japan	Research Site	Fujiidera	Osaka
Japan	Research Site	Fujisawa	Kanagawa
Japan	Research Site	Fukuoika	Fukuoka
Japan	Research Site	Fukuoka	Fukuolka
Japan	Research Site	Fukuoka
Japan	Research Site	Gifu-shi	Gifu
Japan	Research Site	Hachioji	Tokyo
Japan	Research Site	Hitachi	Ibaraki
Japan	Research Site	Kashiwa	Chiba
Japan	Research Site	Kawasaki	Kanagawa
Japan	Research Site	Kisarazu	Chiba
Japan	Research Site	Kiso	Nagano
Japan	Research Site	Kiyose	Tokyo
Japan	Research Site	Koriyama	Fukishima
Japan	Research Site	Koriyama	Fukushima
Japan	Research Site	Kurume	Fukuoka
Japan	Research Site	Kyoto
Japan	Research Site	Maebashi	Gunma
Japan	Research Site	Matsumoto	Nagano
Japan	Research Site	Mito	Ibaraki
Japan	Research Site	Nihonmatsu	Fukishima
Japan	Research Site	Nishishirakawa	Fukishima
Japan	Research Site	Nukaya	Fukuoka
Japan	Research Site	Ohtawara	Tochigi
Japan	Research Site	Oita
Japan	Research Site	Sagamihara	Kanagawa
Japan	Research Site	Sakaide	Kagawa
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Setagaya	Tokyo
Japan	Research Site	Shibata	Myagi
Japan	Research Site	Shimonoseki	Yamaguchi
Japan	Research Site	Shinagawa	Tokyo
Japan	Research Site	Shirakawa	Fukushima
Japan	Research Site	Shizuoka
Japan	Research Site	Sugawa	Fukushima
Japan	Research Site	Takamatsu	Kagawa
Japan	Research Site	Toshima-ku	Tokayo
Japan	Research Site	Tottori
Japan	Research Site	Toyonaka	Osaka
Japan	Research Site	Tsukuba	Ibaraki
Japan	Research Site	Yasunaka	Gunma
Japan	Research Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.	Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.	Up to 24 weeks	No
Secondary	Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment	Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.	up to 4 weeks	No
Secondary	Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment	Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.	Up to 12 weeks	No