Reflux Esophagitis Phase III Study (Initial Treatment)

This study has been completed.

Study NCT00633932 Information provided by AstraZeneca

First Received on March 4, 2008. Last Updated on December 2, 2010 History of Changes

Results First Received: December 10, 2009

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
Condition:	Reflux Esophagitis
Interventions:	Drug: Esomeprazole Drug: Omeprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).

Reporting Groups

	Description
Experimental: Esomeprazole 40mg	Esomeprazole 40mg once daily
Experimental: Esomeprazole 20mg	Esomeprazole 20mg once daily
Comparator: Omeprazole 20mg	Omeprazole 20mg once daily

Participant Flow: Overall Study

	Experimental: Esomeprazole 40mg	Experimental: Esomeprazole 20mg	Comparator: Omeprazole 20mg
STARTED	191 ^[1]	190 ^[1]	191 ^[1]
COMPLETED	179	176	180
NOT COMPLETED	12	14	11
Adverse Event	1	3	4
Withdrawal by Subject	3	9	1
Lost to Follow-up	1	0	2
Protocol Violation	5	2	3
Physician Decision	0	0	1
Doctor's judgement	1	0	0
Moved Away	1	0	0

[1]	Randomised

Baseline Characteristics

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Reporting Groups

	Description
Experimental: Esomeprazole 40mg	Esomeprazole 40mg once daily
Experimental: Esomeprazole 20mg	Esomeprazole 20mg once daily
Comparator: Omeprazole 20mg	Omeprazole 20mg once daily

Baseline Measures

	Experimental: Esomeprazole 40mg	Experimental: Esomeprazole 20mg	Comparator: Omeprazole 20mg	Total
Number of Participants [units: participants]	191	190	191	572
Age, Customized [units: Participants]
< 65 years	127	135	126	388
65 - 74 years	47	36	44	127
>= 75 years	16	18	20	54
Missing	1	1	1	3
Gender, Customized [units: Participants]
Male	139	137	134	410
Female	51	52	56	159
Missing	1	1	1	3

Outcome Measures

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1. Primary:

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". [ Time Frame: 8 weeks ]

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2. Secondary:

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All PIs were prohibited to disclose all information related to this study withiout AZ approval before this study was completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Tore Lind / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00633932 History of Changes
Other Study ID Numbers:	D961HC00002
Study First Received:	March 4, 2008
Results First Received:	December 10, 2009
Last Updated:	December 2, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency