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:	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 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:

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 recurrence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: throughout the treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence/absence of recurrence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: at Week 4 or before and Week 12 or before ] [ Designated as safety issue: No ]

Enrollment:	540
Study Start Date:	January 2008
Study Completion Date:	May 2009

Arms	Assigned Interventions
1: Experimental Esomeprazole and Omeprazole	Drug: Esomeprazole 10mg once daily oral administration Drug: Omeprazole 10mg once daily oral administration
2: Experimental Esomeprazole	Drug: Esomeprazole 20mg once daily oral administration

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

Show 44 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:	D961HC00006
Study First Received:	March 4, 2008
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00634114 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Reflux Esophagitis

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 February 08, 2010