Trial Outcomes & Findings for A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease (NCT NCT00165672)
NCT ID: NCT00165672
Last Updated: 2011-10-05
Results Overview
Mean and standard deviation of percent time pH\<4.0 on 24 hour esophageal pH monitoring.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2011-10-05
Participant Flow
This study was recruited at 13 centers in Japan during the period of May-2005 to Oct-2005.
Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid and patients for whom percent time with pH \<4.0 \>0% during the 24 hour esophageal pH monitoring at the end of the observation period.
Participant milestones
| Measure |
E3810 Pariet (Rabeprazole Sodium) 5 mg
E3810 5 mg: once daily orally for 4 weeks
|
E3810 Pariet (Rabeprazole Sodium) 10 mg
E3810 10 mg: once daily orally for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
E3810 Pariet (Rabeprazole Sodium) 5 mg
E3810 5 mg: once daily orally for 4 weeks
|
E3810 Pariet (Rabeprazole Sodium) 10 mg
E3810 10 mg: once daily orally for 4 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
E3810 Pariet (Rabeprazole Sodium) 5 mg
n=9 Participants
E3810 5 mg: once daily orally for 4 weeks
|
E3810 Pariet (Rabeprazole Sodium) 10 mg
n=9 Participants
E3810 10 mg: once daily orally for 4 weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.6 years
STANDARD_DEVIATION 20.0 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period)
Mean and standard deviation of percent time pH\<4.0 on 24 hour esophageal pH monitoring.
Outcome measures
| Measure |
E3810 Pariet (Rabeprazole Sodium) 5 mg
n=9 Participants
E3810 5 mg: once daily orally for 4 weeks
|
E3810 Pariet (Rabeprazole Sodium) 10 mg
n=9 Participants
E3810 10 mg: once daily orally for 4 weeks
|
|---|---|---|
|
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).
Baseline
|
6.72 Percent Time
Standard Deviation 5.30
|
7.03 Percent Time
Standard Deviation 4.76
|
|
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).
4 weeks
|
1.38 Percent Time
Standard Deviation 0.79
|
0.87 Percent Time
Standard Deviation 1.22
|
Adverse Events
E3810 Pariet (Rabeprazole Sodium) 5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
E3810 Pariet (Rabeprazole Sodium) 10 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
E3810 Pariet (Rabeprazole Sodium) 5 mg
n=13 participants at risk
E3810 5 mg: once daily orally for 4 weeks
|
E3810 Pariet (Rabeprazole Sodium) 10 mg
n=13 participants at risk
E3810 10 mg: once daily orally for 4 weeks
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Number of events 4
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 2
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Early satiety
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
Additional Information
Nobuyuki Sugisaki, Study Director
Eisai Co.,Ltd. Eisai Product Creation Systems
Phone: +81-3-3817-3908
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place