Trial Outcomes & Findings for Maintenance Intermittent Therapy for Symptomatic GERD Patients (NCT NCT00165841)
NCT ID: NCT00165841
Last Updated: 2013-05-20
Results Overview
The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
6 months double-blind maintenance phase
Results posted on
2013-05-20
Participant Flow
This study was recruited at 47 centers in the US during the period of 7-Oct-2004 and 12-Dec-2005.
After enrollment and before randomization (treatment assignment), there was a 2-week placebo run-in phase followed by a 4-week open-label Acute Phase during which subjects were treated with rabeprazole 20 mg once daily for the treatment of heartburn. Note the below participant flow is based on Safety Population (total 200 subjects).
Participant milestones
| Measure |
Rabeprazole 20 mg
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
Placebo
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
97
|
|
Overall Study
COMPLETED
|
73
|
35
|
|
Overall Study
NOT COMPLETED
|
30
|
62
|
Reasons for withdrawal
| Measure |
Rabeprazole 20 mg
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
Placebo
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
6
|
33
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
6
|
8
|
|
Overall Study
Other
|
3
|
5
|
|
Overall Study
Medication Noncompliance
|
1
|
1
|
Baseline Characteristics
Maintenance Intermittent Therapy for Symptomatic GERD Patients
Baseline characteristics by cohort
| Measure |
Rabeprazole 20 mg
n=96 Participants
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
|
Placebo
n=91 Participants
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.0 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
138 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
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months double-blind maintenance phasePopulation: Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.
The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.
Outcome measures
| Measure |
Rabeprazole 20 mg
n=96 Participants
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
|
Placebo
n=91 Participants
Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
|
|---|---|---|
|
The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).
|
82.58 Percentage of Days
Standard Deviation 14.39
|
62.17 Percentage of Days
Standard Deviation 29.93
|
SECONDARY outcome
Timeframe: 6-month maintenance phaseThe percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-month maintenance phaseThe percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month
Outcome measures
Outcome data not reported
Adverse Events
Rabeprazole 20 mg
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 20 mg
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
Placebo
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
|---|---|---|
|
Gastrointestinal disorders
Gallstone pancreatitis
|
0.00%
0/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
1.0%
1/97 • Number of events 1 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
1.0%
1/97 • Number of events 1 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
General disorders
Chest pain
|
0.97%
1/103 • Number of events 1 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
0.00%
0/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Nervous system disorders
Schizoaffective disorder/depression
|
0.97%
1/103 • Number of events 1 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
0.00%
0/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
Other adverse events
| Measure |
Rabeprazole 20 mg
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
Placebo
Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
7/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
1.0%
1/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Gastrointestinal disorders
Erosive gastritis
|
1.9%
2/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
4.1%
4/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.8%
6/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
4.1%
4/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
5/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
3.1%
3/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Gastrointestinal disorders
Esophageal erosion
|
1.9%
2/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
6.2%
6/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Gastrointestinal disorders
Esophagitis
|
3.9%
4/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
5.2%
5/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Infections and infestations
Viral gastroenteritis
|
0.00%
0/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
4.1%
4/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Infections and infestations
Sinusitis
|
1.9%
2/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
4.1%
4/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Nervous system disorders
Headache
|
4.9%
5/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
3.1%
3/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
5/103 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
2.1%
2/97 • 6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
|
Additional Information
Yufang Lu, 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