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To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E3810 | Drug | E3810 5mg: once daily orally for 4 weeks |
| |
| E3810 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Relief of Heartburn at Final Evaluation | "Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days | 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>
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 the 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 |
|---|---|---|---|---|---|---|
| Aichi-Gun | Aichi-ken | 480-1103 | Japan | |||
Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid were transferred to treatment period (randomized double-blind) of placebo, E3810 5 or 10 mg/day for four weeks.
This study was recruited at 35 centers in Japan during the period of Sep-2004 to Oct-2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | once daily orally for 4 weeks |
| FG001 | E3810 5 mg | E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
E3810 10mg: once daily orally for 4 weeks |
|
| Placebo | Drug | Placebo: once daily orally for 4 weeks |
|
| Nagoya |
| Aichi-ken |
| 466-0065 |
| Japan |
| Nagoya | Aichi-ken | 467-0001 | Japan |
| Chikushino-shi | Fukuoka | 818-0024 | Japan |
| Chikushino-shi | Fukuoka | 818-0067 | Japan |
| Fukuoka | Fukuoka | 813-0003 | Japan |
| Kitakyushu | Fukuoka | 807-1262 | Japan |
| Maebashi | Gunma | 371-0034 | Japan |
| Hiroshima | Hiroshima | 730-0052 | Japan |
| Hiroshima | Hiroshima | 734-0037 | Japan |
| Sapporo | Hokkaido-Prefecture | 003-0021 | Japan |
| Sapporo | Hokkaido-Prefecture | 060-0061 | Japan |
| Sapporo | Hokkaido-Prefecture | 060-0814 | Japan |
| Kochi | Kochi | 780-0901 | Japan |
| Kyoto | Kyoto | 602-0000 | Japan |
| Kyoto | Kyoto | 606-8397 | Japan |
| Sandai | Miyagi | 980-0872 | Japan |
| Sendai | Miyagi | 984-0075 | Japan |
| Moriguchi | Osaka | 570-0021 | Japan |
| Osaka | Osaka | 530-0012 | Japan |
| Osaka | Osaka | 536-0002 | Japan |
| Osaka | Osaka | 545-0051 | Japan |
| Saga | Saga-ken | 849-0937 | Japan |
| Kawaguchi | Saitama | 332-0021 | Japan |
| Izumo | Shimane | 693-0021 | Japan |
| Matsue | Shimane | 690-0886 | Japan |
| Hamamatsu | Shizuoka | 431-3125 | Japan |
| Shinagawa-ku | Tokyo | 140-0011 | Japan |
| Shinjuku-ku | Tokyo | 162-0052 | Japan |
| Sanyōonoda | Yamaguchi | 756-0076 | Japan |
| Sanyōonoda | Yamaguchi | 757-0002 | Japan |
| Ube | Yamaguchi | 755-0004 | Japan |
| Ube | Yamaguchi | 755-0046 | Japan |
| Ube | Yamaguchi | 755-0067 | Japan |
| Ube | Yamaguchi | 755-0077 | Japan |
| FG002 | E3810 10 mg | E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | once daily orally for 4 weeks |
| BG001 | E3810 5 mg | E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks |
| BG002 | E3810 10 mg | E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks |
| BG003 | 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 | Full Analysis Set Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants With Complete Relief of Heartburn at Final Evaluation | "Heartburn diary" will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days | The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS). | Posted | Number | Percentage of participants | 4 weeks |
|
|
|
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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 | Placebo | once daily orally for 4 weeks | 0 | 91 | 32 | 91 | ||
| EG001 | E3810 5 mg | E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks | 1 | 93 | 32 | 93 | ||
| EG002 | E3810 10 mg | E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks | 0 | 102 | 37 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric mucosal lesion | Gastrointestinal disorders | These AEs occurred 23days after the end of administration. |
| ||
| Reflux oesophagitis | Gastrointestinal disorders | These AEs occurred 23days after the end of administration. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Cystitis | Infections and infestations |
| |||
| Bronchitis acute | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Acute tonsillitis | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Orchitis | Infections and infestations |
| |||
| Tonsillitis | Infections and infestations |
| |||
| Laryngopharyngitis | Infections and infestations |
| |||
| Lymphadenitis | Blood and lymphatic system disorders |
| |||
| Gout | Metabolism and nutrition disorders |
| |||
| Conversion disorder | Psychiatric disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Migraine | Nervous system disorders |
| |||
| Paraesthesia oral | Nervous system disorders |
| |||
| Dry eye | Eye disorders |
| |||
| Palpitations | Cardiac disorders |
| |||
| Flushing | Vascular disorders |
| |||
| Haemorrhage subcutaneous | Vascular disorders |
| |||
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngolaryngeal discomfort | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Gastrooesophageal reflux disease | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Eructation | Gastrointestinal disorders |
| |||
| Flatulence | Gastrointestinal disorders |
| |||
| Gingival swelling | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Abdominal pain lower | Gastrointestinal disorders |
| |||
| Gingivitis | Gastrointestinal disorders |
| |||
| Mouth haemorrhage | Gastrointestinal disorders |
| |||
| Stomach discomfort | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Tongue disorder | Gastrointestinal disorders |
| |||
| Haemorrhoidal haemorrhage | Gastrointestinal disorders |
| |||
| Hypoaesthesia oral | Gastrointestinal disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis allergic | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Erythema multiforme | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| Groin pain | Musculoskeletal and connective tissue disorders |
| |||
| Sensation of heaviness | Musculoskeletal and connective tissue disorders |
| |||
| Pollakiuria | Renal and urinary disorders |
| |||
| Dysmenorrhoea | Reproductive system and breast disorders |
| |||
| Epididymitis | Reproductive system and breast disorders |
| |||
| Early satiety | General disorders |
| |||
| Malaise | General disorders |
| |||
| Oedema | General disorders |
| |||
| Thirst | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Chest discomfort | General disorders |
| |||
| Blood lactate dehydrogenase increased | Investigations |
| |||
| Gamma-glutamyltransferase increased | Investigations |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Blood triglycerides increased | Investigations |
| |||
| Neutrophil count increased | Investigations |
| |||
| White blood cell count decreased | Investigations |
| |||
| White blood cell count increased | Investigations |
| |||
| Blood pressure increased | Investigations |
| |||
| Blood urea increased | Investigations |
| |||
| C-reactive protein increased | Investigations |
| |||
| Neutrophil percentage increased | Investigations |
| |||
| Lymphocyte percentage decreased | Investigations |
| |||
| Injury | Injury, poisoning and procedural complications |
| |||
| Joint sprain | Injury, poisoning and procedural complications |
| |||
| Rib fracture | Injury, poisoning and procedural complications |
| |||
| Contusion | 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 |
|