Reflux Esophagitis Phase III Study (Maintenance Treatment)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00634114
First received: March 4, 2008
Last updated: May 18, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Reflux Esophagitis |
Drug: Esomeprazole Drug: Omeprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
GERD
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]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.
- Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 540 |
| Study Start Date: | January 2008 |
| Study Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Esomeprazole and Omeprazole
|
Drug: Esomeprazole
10mg once daily oral administration
Other Name: Nexium
Drug: Omeprazole
10mg once daily oral administration
Other Name: Prilosec
|
|
Experimental: 2
Esomeprazole
|
Drug: Esomeprazole
20mg once daily oral administration
Other Name: Nexium
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634114
Locations
| Japan | |
| Research Site | |
| Kashiwa, Chiba, Japan | |
| Research Site | |
| Kisarazu, Chiba, Japan | |
| Research Site | |
| Koriyama, Fukishima, Japan | |
| Research Site | |
| Nihonmatsu, Fukishima, Japan | |
| Research Site | |
| Nishishirakawa, Fukishima, Japan | |
| Research Site | |
| Fukuoika, Fukuoka, Japan | |
| Research Site | |
| Kurume, Fukuoka, Japan | |
| Research Site | |
| Nukaya, Fukuoka, Japan | |
| Research Site | |
| Fukuoka, Fukuolka, Japan | |
| Research Site | |
| Koriyama, Fukushima, Japan | |
| Research Site | |
| Shirakawa, Fukushima, Japan | |
| Research Site | |
| Sugawa, Fukushima, Japan | |
| Research Site | |
| Gifu-shi, Gifu, Japan | |
| Research Site | |
| Maebashi, Gunma, Japan | |
| Research Site | |
| Yasunaka, Gunma, Japan | |
| Research Site | |
| Sapporo, Hokkaido, Japan | |
| Research Site | |
| Hitachi, Ibaraki, Japan | |
| Research Site | |
| Mito, Ibaraki, Japan | |
| Research Site | |
| Tsukuba, Ibaraki, Japan | |
| Research Site | |
| Sakaide, Kagawa, Japan | |
| Research Site | |
| Takamatsu, Kagawa, Japan | |
| Research Site | |
| Fujisawa, Kanagawa, Japan | |
| Research Site | |
| Kawasaki, Kanagawa, Japan | |
| Research Site | |
| Sagamihara, Kanagawa, Japan | |
| Research Site | |
| Yokohama, Kanagawa, Japan | |
| Research Site | |
| Shibata, Myagi, Japan | |
| Research Site | |
| Kiso, Nagano, Japan | |
| Research Site | |
| Matsumoto, Nagano, Japan | |
| Research Site | |
| Fujiidera, Osaka, Japan | |
| Research Site | |
| Toyonaka, Osaka, Japan | |
| Research Site | |
| Ohtawara, Tochigi, Japan | |
| Research Site | |
| Toshima-ku, Tokayo, Japan | |
| Research Site | |
| Adachi, Tokyo, Japan | |
| Research Site | |
| Hachioji, Tokyo, Japan | |
| Research Site | |
| Kiyose, Tokyo, Japan | |
| Research Site | |
| Setagaya, Tokyo, Japan | |
| Research Site | |
| Shinagawa, Tokyo, Japan | |
| Research Site | |
| Shimonoseki, Yamaguchi, Japan | |
| Research Site | |
| Akita, Japan | |
| Research Site | |
| Fukuoka, Japan | |
| Research Site | |
| Kyoto, Japan | |
| Research Site | |
| Oita, Japan | |
| Research Site | |
| Shizuoka, Japan | |
| Research Site | |
| Tottori, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Maotsugu Oyama, MD, PhD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Tore Lind / Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00634114 History of Changes |
| Other Study ID Numbers: | D961HC00006 |
| Study First Received: | March 4, 2008 |
| Results First Received: | May 18, 2010 |
| Last Updated: | May 18, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
Reflux Esophagitis |
Additional relevant MeSH terms:
|
Esophagitis Esophagitis, Peptic Gastroesophageal Reflux Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Peptic Ulcer Esophageal Motility Disorders |
Deglutition Disorders Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013