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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00236184
• Collaborator: (none)
• Enrollment: 629
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 19.7

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Drug: rabeprazole sodium; Other: Placebo	Phase 3

Detailed Description

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 629 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Oral placebo tablet	Other: Placebo; Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Experimental: Rabeprazole sodium 10 mg oral rabeprazole 10 mg enteric-coated tablet	Drug: rabeprazole sodium; Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.; Other Names: Aciphex

Outcome Measures

Primary Outcome Measures

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

   Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.

Secondary Outcome Measures

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

   comparison between placebo and treatment will be analyzed using two-sample t-test.

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

   comparison between placebo and treatment will be analyzed using two-sample t-test.

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

   comparison between placebo and treatment will be analyzed using two-sample t-test.

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

   comparison between placebo and treatment will be analyzed using two-sample t-test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female patients > 18 years of age.

2. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.

3. Patients must report a history of heartburn at least two days per week over the past month.

Exclusion Criteria:

1. History of erosive esophagitis verified by endoscopy.

2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.

3. Patients who have a history of Barrett's esophagus or esophageal stricture.

4. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.

5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeffrey L. Newman	Vista	California	United States	92084

Sponsors and Collaborators

• Eisai Inc.

Investigators

• Study Director: Yufang Lu, MD, PhD, Eisai Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00236184
• Other Study ID Numbers: E3810-A001-313
• First Posted: Oct 12, 2005
• Last Update Posted: Apr 6, 2010
• Last Verified: Mar 1, 2010

• Additional relevant MeSH terms: Heartburn; Rabeprazole

Study Results

Participant Flow

Recruitment Details	This study was recruited at 39 centers in the US during the period of 10-Oct-2005 and 16-Mar-2006.
Pre-assignment Detail	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.

Arm/Group Title	Placebo	Rabeprazole 10 mg
Arm/Group Description
Period Title: Overall Study
STARTED	310	319
COMPLETED	292	308
NOT COMPLETED	18	11

Baseline Characteristics

Arm/Group Title	Placebo	Rabeprazole 10 mg	Total
Arm/Group Description	oral placebo tablet	oral enteric-coated tablet	Total of all reporting groups
Overall Participants	310	319	629
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	285 91.9%	298 93.4%	583 92.7%
>=65 years	25 8.1%	21 6.6%	46 7.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.4 (13.3)	44.1 (14.4)	44.7 (13.8)
Sex: Female, Male (Count of Participants)
Female	198 63.9%	186 58.3%	384 61%
Male	112 36.1%	133 41.7%	245 39%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.6%	2 0.6%	4 0.6%
Asian	4 1.3%	5 1.6%	9 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	25 8.1%	31 9.7%	56 8.9%
White	236 76.1%	248 77.7%	484 76.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	43 13.9%	33 10.3%	76 12.1%
Region of Enrollment (participants) [Number]
United States	310 100%	319 100%	629 100%

Outcome Measures

1. Secondary Outcome

Title	Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
Description	comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame	14-day treatment period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
Description	comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame	14-day treatment period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
Description	comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame	14-day treatment period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
Description	comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame	14-day treatment period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Primary Outcome

Title	Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
Description	Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
Time Frame	first 24 hours

Outcome Measure Data

Analysis Population Description

The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.

Arm/Group Title	Placebo	Rabeprazole 10 mg
Arm/Group Description
Measure Participants	306	318
Number [participants]	114 36.8%	163 51.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rabeprazole 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Arm/Group Title	Placebo		Rabeprazole 10 mg
Arm/Group Description
All Cause Mortality
	Placebo		Rabeprazole 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Rabeprazole 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/310 (0.6%)		1/319 (0.3%)
Cardiac disorders
Chest pain	0/310 (0%)	0	1/319 (0.3%)	1
Gastrointestinal disorders
Appendicitis perforated	1/310 (0.3%)	1	0/319 (0%)	0
Pregnancy, puerperium and perinatal conditions
abortion spontaneous	1/310 (0.3%)	1	0/319 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Rabeprazole 10 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/310 (1.3%)		7/319 (2.2%)
Infections and infestations
Nasopharyngitis	4/310 (1.3%)		7/319 (2.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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