Trial Outcomes & Findings for E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers (NCT NCT00236184)

Last Updated: 2010-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

629 participants

Primary outcome timeframe

first 24 hours

Results posted on

2010-04-06

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Placebo	Rabeprazole 10 mg
Overall Study STARTED	310	319
Overall Study COMPLETED	292	308
Overall Study NOT COMPLETED	18	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	Rabeprazole 10 mg
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	3	4
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	3	0
Overall Study Protocol Violation	3	0
Overall Study non-compliance with study drug	2	1
Overall Study other	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=310 Participants oral placebo tablet	Rabeprazole 10 mg n=319 Participants oral enteric-coated tablet	Total n=629 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	285 Participants n=5 Participants	298 Participants n=7 Participants	583 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Age Continuous	45.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	44.1 years STANDARD_DEVIATION 14.4 • n=7 Participants	44.7 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	198 Participants n=5 Participants	186 Participants n=7 Participants	384 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	133 Participants n=7 Participants	245 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	236 Participants n=5 Participants	248 Participants n=7 Participants	484 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	43 Participants n=5 Participants	33 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	310 participants n=5 Participants	319 participants n=7 Participants	629 participants n=5 Participants

PRIMARY outcome

Timeframe: first 24 hours

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=306 Participants	Rabeprazole 10 mg n=318 Participants
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.	114 participants	163 participants

SECONDARY outcome

Timeframe: 14-day treatment period.

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=310 participants at risk	Rabeprazole 10 mg n=319 participants at risk
Gastrointestinal disorders Appendicitis perforated	0.32% 1/310 • Number of events 1	0.00% 0/319
Pregnancy, puerperium and perinatal conditions abortion spontaneous	0.32% 1/310 • Number of events 1	0.00% 0/319
Cardiac disorders Chest pain	0.00% 0/310	0.31% 1/319 • Number of events 1

Other adverse events

Other adverse events
Measure	Placebo n=310 participants at risk	Rabeprazole 10 mg n=319 participants at risk
Infections and infestations Nasopharyngitis	1.3% 4/310	2.2% 7/319

Additional Information

Yufang Lu, MD, PhD, Study Director

Eisai Medical Research Inc.

Phone: 201-403-2500

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER