A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

This study has been completed.

Study NCT00165646 Information provided by Eisai Inc.

First Received on September 12, 2005. Last Updated on July 14, 2011 History of Changes

Results First Received: May 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Non-erosive Gastroesophageal Reflux Disease
Interventions:	Drug: E3810 Drug: Placebo

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
This study was recruited at 35 centers in Japan during the period of Sep-2004 to Oct-2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid were transferred to treatment period (randomized double-blind) of placebo, E3810 5 or 10 mg/day for four weeks.

Reporting Groups

	Description
Placebo	once daily orally for 4 weeks
E3810 5 mg	E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
E3810 10 mg	E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks

Participant Flow: Overall Study

	Placebo	E3810 5 mg	E3810 10 mg
STARTED	93	93	102
COMPLETED	88	88	98
NOT COMPLETED	5	5	4
Adverse Event	1	1	1
Lack of Efficacy	1	2	0
Withdrawal by Subject	0	2	1
Physician Decision	2	0	2
Protocol Violation	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	once daily orally for 4 weeks
E3810 5 mg	E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
E3810 10 mg	E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks

Baseline Measures

	Placebo	E3810 5 mg	E3810 10 mg	Total
Number of Participants [units: participants]	91	93	101	285
Age ^[1] [units: years] Mean ± Standard Deviation	49.7 ± 17.0	46.3 ± 15.3	46.8 ± 15.7	47.6 ± 16.0
Gender [units: participants]
Female	51	55	51	157
Male	40	38	50	128
Race (NIH/OMB) [units: participants]
Asian	91	93	101	285
Region of Enrollment [units: participants]
Japan	91	93	101	285

[1]	Full Analysis Set Population

Outcome Measures

1. Primary:

Percentage of Participants With Complete Relief of Heartburn at Final Evaluation [ 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 NOT 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.

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: Nobuyuki Sugisaki, Study Director
Organization: Eisai Co.,Ltd. Eisai Product Creation Systems
phone: +81-3-3817-3908
e-mail: n-sugisaki@hhc.eisai.co.jp

No publications provided

Responsible Party:	Nobuyuki Sugisaki, Eisai Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00165646 History of Changes
Other Study ID Numbers:	E3810-J081-461
Study First Received:	September 12, 2005
Results First Received:	May 23, 2011
Last Updated:	July 14, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare