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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00634114
Other study ID # D961HC00006
Secondary ID
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
Est. primary completion date
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


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
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