Trial Outcomes & Findings for Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD) (NCT NCT00911534)

Results Overview

Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

305 participants

Primary outcome timeframe

Week 4

Results posted on

2016-02-02

Participant Flow

Out of the 305 participants who were enrolled into the study, 300 participants received the study treatment.

Participant milestones

Participant milestones
Measure	Placebo One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg One RAB ER 50mg capsule, orally, each day for 4 weeks
Overall Study STARTED	147	153
Overall Study COMPLETED	132	137
Overall Study NOT COMPLETED	15	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg One RAB ER 50mg capsule, orally, each day for 4 weeks
Overall Study Adverse Event	4	4
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	2	1
Overall Study Lack of Efficacy	4	1
Overall Study Withdrawal of consent	1	4
Overall Study Other	2	2

Baseline Characteristics

Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=147 Participants One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=153 Participants One RAB ER 50mg capsule, orally, each day for 4 weeks	Total n=300 Participants Total of all reporting groups
Age, Continuous	44.4 Years STANDARD_DEVIATION 13.32 • n=5 Participants	43.8 Years STANDARD_DEVIATION 12.35 • n=7 Participants	44.1 Years STANDARD_DEVIATION 12.82 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	105 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)

Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=153 Participants One RAB ER 50mg capsule, orally, each day for 4 weeks
Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4	21.23 Percentage of Days Standard Deviation 26.8	41.14 Percentage of Days Standard Deviation 34.49

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: ITT

Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=153 Participants One RAB ER 50mg capsule, orally, each day for 4 weeks
Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4 Heartburn (Daytime)	-0.82 Scores on a Scale Standard Deviation 0.65	-1.22 Scores on a Scale Standard Deviation 0.79
Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4 Heartburn (Nighttime)	-0.74 Scores on a Scale Standard Deviation 0.72	-1.17 Scores on a Scale Standard Deviation 0.78
Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4 Regurgitation	-0.49 Scores on a Scale Standard Deviation 0.62	-0.74 Scores on a Scale Standard Deviation 0.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 2 and Week 4

Population: ITT (n=number of participants with evaluable data)

Participants completed a daily symptom diary.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=153 Participants One RAB ER 50mg capsule, orally, each day for 4 weeks
Percentage of Participants With Complete Heartburn Relief Week 2 (n=147, 148)	3.4 Percentage of Participants	15 Percentage of Participants
Percentage of Participants With Complete Heartburn Relief Week 4 (n=147, 148)	7.5 Percentage of Participants	22.2 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 4

Population: ITT

Participants completed a daily symptom diary.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=153 Participants One RAB ER 50mg capsule, orally, each day for 4 weeks
Time to Achieve First 24-Hour Period Without Heartburn	14.4 Days Standard Error 0.84	10.6 Days Standard Error 0.92

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

RAB ER 50mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=147 participants at risk One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule	RAB ER 50mg n=152 participants at risk One RAB ER 50mg capsule, orally, each day for 4 weeks
Hepatobiliary disorders Cholecystitis, acute	0.68% 1/147 • For each participant, from the time participant signed the study consent form until resolution or for up to 30 days after study drug discontinuation, whichever came first. The analysis was performed using the Safety Analysis Set (SAS) defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.	0.00% 0/152 • For each participant, from the time participant signed the study consent form until resolution or for up to 30 days after study drug discontinuation, whichever came first. The analysis was performed using the Safety Analysis Set (SAS) defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.

Other adverse events

Adverse event data not reported

Additional Information

Eisai Inc.

Eisai Call Center

Phone: 888-422-4743

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place