Trial Outcomes & Findings for Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole (NCT NCT00132496)
NCT ID: NCT00132496
Last Updated: 2009-12-03
Results Overview
Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
8 weeks from randomization and end of treatment
Results posted on
2009-12-03
Participant Flow
This study was recruited at 25 centers in the US during the period of 18-Aug-2005 and 1-May-2006.
There was a screening period of up to 2 days before treatment assignment
Participant milestones
| Measure |
Rabeprazole 10 mg
once daily for 8 weeks
|
Rabeprazole 20 mg
once daily for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
57
|
|
Overall Study
COMPLETED
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Rabeprazole 10 mg
once daily for 8 weeks
|
Rabeprazole 20 mg
once daily for 8 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Baseline characteristics by cohort
| Measure |
Rabeprazole 10 mg
n=54 Participants
once daily for 8 weeks
|
Rabeprazole 20 mg
n=57 Participants
once daily for 8 weeks
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
14.2 years
STANDARD_DEVIATION 1.3 • n=93 Participants
|
14.1 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
14.2 years
STANDARD_DEVIATION 1.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
47 participants
n=93 Participants
|
53 participants
n=4 Participants
|
100 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=93 Participants
|
57 participants
n=4 Participants
|
111 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeks from randomization and end of treatmentPopulation: Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.
Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.
Outcome measures
| Measure |
Rabeprazole 10 mg
n=54 Participants
once daily for 8 weeks
|
Rabeprazole 20 mg
n=57 Participants
once daily for 8 weeks
|
|---|---|---|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Cough
|
5 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Nausea
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Upper abdominal pain
|
1 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Diarrhea
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Chest pain
|
0 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Upper respiratory tract infection
|
4 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Bronchitis
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Pharyngitis
|
3 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Sinusitis
|
2 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Nasopharyngitis
|
1 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Otitis media
|
1 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Headache
|
5 Participants
|
6 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Pharyngolaryngeal pain
|
6 Participants
|
5 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Nasal congestion
|
4 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
Total # subjects reporting AEs
|
41 Participants
|
45 Participants
|
Adverse Events
Rabeprazole 10 mg
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Rabeprazole 20 mg
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 10 mg
once daily for 8 weeks
|
Rabeprazole 20 mg
once daily for 8 weeks
|
|---|---|---|
|
Nervous system disorders
Mood swings
|
0.00%
0/54
|
1.8%
1/57 • Number of events 1
|
Other adverse events
| Measure |
Rabeprazole 10 mg
once daily for 8 weeks
|
Rabeprazole 20 mg
once daily for 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
3/54
|
3.5%
2/57
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54
|
3.5%
2/57
|
|
Gastrointestinal disorders
Upper andominal pain
|
1.9%
1/54
|
5.3%
3/57
|
|
General disorders
Chest Pain
|
0.00%
0/54
|
5.3%
3/57
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
4/54
|
5.3%
3/57
|
|
Infections and infestations
Bronchitis
|
5.6%
3/54
|
3.5%
2/57
|
|
Infections and infestations
Pharyngitis
|
5.6%
3/54
|
3.5%
2/57
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54
|
5.3%
3/57
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/54
|
7.0%
4/57
|
|
Infections and infestations
Otitis media
|
1.9%
1/54
|
5.3%
3/57
|
|
Nervous system disorders
Headache
|
9.3%
5/54
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
6/54
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
5/54
|
5.3%
3/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
4/54
|
7.0%
4/57
|
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