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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00633932

Purpose

This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Condition	Intervention	Phase
Reflux Esophagitis	Drug: Esomeprazole Drug: Omeprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis

Resource links provided by NLM:

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:

Presence/absence of Reflux Esophagitis according to Los Angeles classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence/absence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	555
Study Start Date:	December 2007
Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental Esomeprazole 20mg and Omeprazole 20mg	Drug: Esomeprazole 20mg once daily Drug: Omeprazole 20mg once daily
2: Experimental Esomeprazole 40mg and Omeprazole 20mg	Drug: Esomeprazole 40 mg once daily Drug: Omeprazole 20mg once daily

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

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: NCT00633932

Show 41 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Maotsugu Oyama, MD, PhD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Tore Lind / Medical Science Director )
Study ID Numbers:	D961HC00002
Study First Received:	March 4, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00633932 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Reflux Esophagitis

Study placed in the following topic categories:

Esophagitis
Esophagitis, Peptic
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases

Ulcer
Omeprazole
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions
Esophagitis

Esophagitis, Peptic
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

ClinicalTrials.gov processed this record on September 10, 2009