Maintenance Intermittent Therapy for Symptomatic GERD Patients

This study has been completed.

Study NCT00165841 Information provided by Eisai Inc.

First Received on September 13, 2005. Last Updated on December 30, 2009 History of Changes

Results First Received: August 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Gastroesophageal Reflux Disease
Intervention:	Drug: Rabeprazole 20 mg

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 47 centers in the US during the period of 7-Oct-2004 and 12-Dec-2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment and before randomization (treatment assignment), there was a 2-week placebo run-in phase followed by a 4-week open-label Acute Phase during which subjects were treated with rabeprazole 20 mg once daily for the treatment of heartburn. Note the below participant flow is based on Safety Population (total 200 subjects).

Reporting Groups

	Description
Rabeprazole 20 mg	Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
Placebo	Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.

Participant Flow: Overall Study

	Rabeprazole 20 mg	Placebo
STARTED	103	97
COMPLETED	73	35
NOT COMPLETED	30	62
Adverse Event	2	3
Lack of Efficacy	6	33
Lost to Follow-up	4	4
Withdrawal by Subject	7	8
Physician Decision	1	0
Protocol Violation	6	8
Unknown	3	5
Medication Noncompliance	1	1

Baseline Characteristics

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Reporting Groups

	Description
Rabeprazole 20 mg	Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
Placebo	Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).

Baseline Measures

	Rabeprazole 20 mg	Placebo	Total
Number of Participants [units: participants]	96	91	187
Age [units: years] Mean ± Standard Deviation	46.0 ± 11.67	46.6 ± 11.69	46.3 ± 11.66
Gender [units: participants]
Female	64	59	123
Male	32	32	64
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	1	1
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	9	10	19
White	74	64	138
More than one race	0	0	0
Unknown or Not Reported	12	16	28

Outcome Measures

1. Primary:

The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population). [ Time Frame: 6 months double-blind maintenance phase ]

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2. Secondary:

The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase [ Time Frame: 6-month maintenance phase ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase [ Time Frame: 6-month maintenance phase ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: No text entered.

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
No text entered.

Results Point of Contact:

Name/Title: Yufang Lu, Study Director
Organization: Eisai Medical Research Inc.
phone: 201-403-2500

No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Fass R, Delemos B, Nazareno L, Kao R, Xiang J, Lu Y. Clinical trial: maintenance intermittent therapy with rabeprazole 20 mg in patients with symptomatic gastro-oesophageal reflux disease - a double-blind, placebo-controlled, randomized study. Aliment Pharmacol Ther. 2010 May;31(9):950-60. Epub 2010 Feb 2.

Responsible Party:	Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00165841 History of Changes
Other Study ID Numbers:	E3810-A001-203
Study First Received:	September 13, 2005
Results First Received:	August 18, 2009
Last Updated:	December 30, 2009
Health Authority:	United States: Food and Drug Administration