Reflux Esophagitis Phase III Study (Maintenance Treatment) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00634114

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 III

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 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
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Sugawa, Fukushima, Japan
Research Site
Gifu-shi, Gifu, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Yasunaka, Gunma, Japan
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Sapporo, Hokkaido, Japan
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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 February 12, 2012