A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

This study has been completed.

Study NCT00165672 Information provided by Eisai Inc.

First Received on September 12, 2005. Last Updated on September 6, 2011 History of Changes

Results First Received: July 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Non-erosive Gastroesophageal Reflux Disease
Intervention:	Drug: RABEPRAZOLE SODIUM

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 13 centers in Japan during the period of May-2005 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 and patients for whom percent time with pH <4.0 >0% during the 24 hour esophageal pH monitoring at the end of the observation period.

Reporting Groups

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

Participant Flow: Overall Study

	E3810 Pariet (Rabeprazole Sodium) 5 mg	E3810 Pariet (Rabeprazole Sodium) 10 mg
STARTED	13	13
COMPLETED	13	12
NOT COMPLETED	0	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	E3810 Pariet (Rabeprazole Sodium) 5 mg	E3810 Pariet (Rabeprazole Sodium) 10 mg	Total
Number of Participants [units: participants]	9	9	18
Age ^[1] [units: years] Mean ± Standard Deviation	40.6 ± 20.0	42.7 ± 15.8	41.6 ± 17.5
Gender [units: participants]
Female	3	4	7
Male	6	5	11
Race (NIH/OMB) [units: participants]
Asian	9	9	18
Region of Enrollment [units: participants]
Japan	9	9	18

[1]	This number is the population for data analysis of clinical pharmacology.

Outcome Measures

1. Primary:

The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring). [ Time Frame: Baseline and 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:	NCT00165672 History of Changes
Other Study ID Numbers:	E3810-J081-462
Study First Received:	September 12, 2005
Results First Received:	July 19, 2011
Last Updated:	September 6, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare