Trial Outcomes & Findings for E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers (NCT NCT00236197)

NCT ID: NCT00236197

Last Updated: 2009-11-11

Results Overview

The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 619 participants
• Primary outcome timeframe: First 24 hours
• Results posted on: 2009-11-11

Participant Flow

This study was recruited at 38 centers in the US during the period of 13-Oct-2005 and 21-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

Measure	Placebo	Rabeprazole 10 mg
Overall Study STARTED	312	307
Overall Study COMPLETED	307	293
Overall Study NOT COMPLETED	5	14

Reasons for withdrawal

Measure	Placebo	Rabeprazole 10 mg
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	1	5
Overall Study Protocol Violation	0	3
Overall Study Medication non-compliance	1	2
Overall Study Other	0	2

Baseline Characteristics

E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Baseline characteristics by cohort

Measure	Placebo n=312 Participants	Rabeprazole 10 mg n=307 Participants	Total n=619 Participants Total of all reporting groups
Age Continuous	48.2 years STANDARD_DEVIATION 14.7 • n=5 Participants	48.8 years STANDARD_DEVIATION 14.0 • n=7 Participants	48.5 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	204 Participants n=5 Participants	207 Participants n=7 Participants	411 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	100 Participants n=7 Participants	208 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	12 Participants n=7 Participants	19 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	39 Participants n=5 Participants	31 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) White	192 Participants n=5 Participants	192 Participants n=7 Participants	384 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	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Region of Enrollment United States	312 participants n=5 Participants	307 participants n=7 Participants	619 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.

The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.

Outcome measures

Measure	Placebo n=311 Participants	Rabeprazole 10 mg n=306 Participants
Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population	100 Participants	121 Participants

SECONDARY outcome

Timeframe: 14-day treatment period.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14-day randomized treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 day randomized treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 day randomized treatment period

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Rabeprazole 10 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=312 participants at risk	Rabeprazole 10 mg n=307 participants at risk
Infections and infestations Upper respiratory tract infection	1.6% 5/312	0.65% 2/307

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