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Reflux Esophagitis Phase III Study (Maintenance Treatment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634114
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : June 17, 2010
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Reflux Esophagitis Drug: Esomeprazole Drug: Omeprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. [ Time Frame: Up to 24 weeks ]
    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 :
  1. Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks ]
    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.

  2. Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment [ Time Frame: Up to 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634114


Locations
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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
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Fukuoika, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Nukaya, Fukuoka, Japan
Research Site
Fukuoka, Fukuolka, Japan
Research Site
Koriyama, Fukushima, Japan
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Shirakawa, Fukushima, Japan
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Sugawa, Fukushima, Japan
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Gifu-shi, Gifu, Japan
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Maebashi, Gunma, Japan
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Yasunaka, Gunma, Japan
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Sapporo, Hokkaido, Japan
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Hitachi, Ibaraki, Japan
Research Site
Mito, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Sakaide, Kagawa, Japan
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Takamatsu, Kagawa, Japan
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Fujisawa, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Shibata, Myagi, Japan
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Kiso, Nagano, Japan
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Matsumoto, Nagano, Japan
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Fujiidera, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
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Ohtawara, Tochigi, Japan
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Toshima-ku, Tokayo, Japan
Research Site
Adachi, Tokyo, Japan
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Hachioji, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
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Setagaya, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shimonoseki, Yamaguchi, Japan
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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
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Study Director: Maotsugu Oyama, MD, PhD AstraZeneca
More Information
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Responsible Party: Tore Lind / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00634114    
Other Study ID Numbers: D961HC00006
First Posted: March 12, 2008    Key Record Dates
Results First Posted: June 17, 2010
Last Update Posted: June 17, 2010
Last Verified: May 2010
Keywords provided by AstraZeneca:
Reflux Esophagitis
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
 Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esomeprazole
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action