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| Name | Class |
|---|---|
| Eisai Limited | INDUSTRY |
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RABEPRAZOLE SODIUM | Drug | rabeprazole sodium 5 mg: once daily orally for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring. | Baseline and 4 weeks |
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Inclusion Criteria:
The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
<For the observation period>
1) The symptom is a burning sensation arising from the stomach or the lower chest.
2) The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
3. Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
4. Patients who are 20 years old or older at the time of obtaining consent.
5. Patients who are informed of the objective and details of this study and give written consent for study entry.
<For the treatment period>
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Nobuyuki Sugisaki | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 467-0001 | Japan | |||
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.
This study was recruited at 13 centers in Japan during the period of May-2005 to Oct-2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | E3810 Pariet (Rabeprazole Sodium) 5 mg | E3810 5 mg: once daily orally for 4 weeks |
| FG001 | E3810 Pariet (Rabeprazole Sodium) 10 mg | E3810 10 mg: once daily orally for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RABEPRAZOLE SODIUM |
| Drug |
rabeprazole sodium 10 mg: once daily orally for 4 weeks |
|
| Fukuoka |
| Fukuoka |
| 810-0001 |
| Japan |
| Fukuoka | Fukuoka | 811-0213 | Japan |
| Yukuhashi | Fukuoka | 824-0026 | Japan |
| Hiroshima | Hiroshima | 734-0037 | Japan |
| Osaka | Osaka | 530-0012 | Japan |
| Osaka | Osaka | 545-0051 | Japan |
| Saga | Saga-ken | 849-0937 | Japan |
| Ōtsu | Shiga | 520-2121 | Japan |
| Izumo | Shimane | 693-0021 | Japan |
| Bunkyo-ku | Tokyo | 113-0022 | Japan |
| Shinjuku-ku | Tokyo | 162-0052 | Japan |
| Ube | Yamaguchi | 755-0046 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | E3810 Pariet (Rabeprazole Sodium) 5 mg | E3810 5 mg: once daily orally for 4 weeks |
| BG001 | E3810 Pariet (Rabeprazole Sodium) 10 mg | E3810 10 mg: once daily orally for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | This number is the population for data analysis of clinical pharmacology. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring. | The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period) | Posted | Mean | Standard Deviation | Percent Time | Baseline and 4 weeks |
|
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E3810 Pariet (Rabeprazole Sodium) 5 mg | E3810 5 mg: once daily orally for 4 weeks | 0 | 13 | 6 | 13 | ||
| EG001 | E3810 Pariet (Rabeprazole Sodium) 10 mg | E3810 10 mg: once daily orally for 4 weeks | 0 | 13 | 10 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Tympanic membrane perforation | Ear and labyrinth disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Gastrooesophageal reflux disease | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Stomach discomfort | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Dysuria | Renal and urinary disorders |
| |||
| Early satiety | General disorders |
| |||
| Blood lactate dehydrogenase increased | Investigations |
| |||
| Platelet count decreased | Investigations |
| |||
| Fall | Injury, poisoning and procedural complications |
| |||
| Muscle rupture | Injury, poisoning and procedural complications |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nobuyuki Sugisaki, Study Director | Eisai Co.,Ltd. Eisai Product Creation Systems | +81-3-3817-3908 | n-sugisaki@hhc.eisai.co.jp |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
|