E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

This study has been completed.

Study NCT00236184 Information provided by Eisai Inc.

First Received on October 10, 2005. Last Updated on March 30, 2010 History of Changes

Results First Received: August 26, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Heartburn
Interventions:	Drug: rabeprazole sodium Other: 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 39 centers in the US during the period of 10-Oct-2005 and 16-Mar-2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The screening phase (1 to 2 weeks) included a 1-week single-blind placebo run-in phase in order to determine baseline heartburn frequency and diary compliance. At the end of the run-in phase, subjects continued the study and entered the randomized treatment phase if they meet the study criteria.

Reporting Groups

	Description
Placebo	No text entered.
Rabeprazole 10 mg	No text entered.

Participant Flow: Overall Study

	Placebo	Rabeprazole 10 mg
STARTED	310	319
COMPLETED	292	308
NOT COMPLETED	18	11
Adverse Event	5	2
Lack of Efficacy	0	1
Lost to Follow-up	3	4
Physician Decision	1	1
Withdrawal by Subject	3	0
Protocol Violation	3	0
non-compliance with study drug	2	1
other	1	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	oral placebo tablet
Rabeprazole 10 mg	oral enteric-coated tablet

Baseline Measures

	Placebo	Rabeprazole 10 mg	Total
Number of Participants [units: participants]	310	319	629
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	285	298	583
>=65 years	25	21	46
Age [units: years] Mean ± Standard Deviation	45.4 ± 13.3	44.1 ± 14.4	44.7 ± 13.8
Gender [units: participants]
Female	198	186	384
Male	112	133	245
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	2	2	4
Asian	4	5	9
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	25	31	56
White	236	248	484
More than one race	0	0	0
Unknown or Not Reported	43	33	76
Region of Enrollment [units: participants]
United States	310	319	629

Outcome Measures

1. Primary:

Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. [ Time Frame: first 24 hours ]

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2. Secondary:

Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ]

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

3. Secondary:

Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ]

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

4. Secondary:

Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ]

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

5. Secondary:

Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ]

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, MD, PhD, Study Director
Organization: Eisai Medical Research Inc.
phone: 201-403-2500

No publications provided

Responsible Party:	Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00236184 History of Changes
Other Study ID Numbers:	E3810-A001-313
Study First Received:	October 10, 2005
Results First Received:	August 26, 2009
Last Updated:	March 30, 2010
Health Authority:	United States: Food and Drug Administration