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The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.
This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks. The 8-week Treatment Period (unblinded) was followed by a 52-week Maintenance Period (blinded). Participants with cure (modified Los Angeles Classification Grade N or Grade M) at the final endoscopy of the Treatment Period were entered into the Maintenance Period. Participants without cure were discontinued from the study. The participants in the Treatment Period were randomized to take Arm C or Arm D at a ratio of 1:1. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
| |
| Arm C | Experimental |
| |
| Arm D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | Drug | Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Non-recurrence at Week 52 | The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Non-recurrence at Weeks 12 and 24 | The non-recurrence rate (up to 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. The 95% CI was calculated by normal approximation. |
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Inclusion Criteria:
Subjects fulfilling all of the below criteria shall be eligible for the study:
Exclusion Criteria:
Subjects fulfilling any of the following criteria shall be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29188387 | Derived | Kinoshita Y, Kato M, Fujishiro M, Masuyama H, Nakata R, Abe H, Kumagai S, Fukushima Y, Okubo Y, Hojo S, Kusano M. Efficacy and safety of twice-daily rabeprazole maintenance therapy for patients with reflux esophagitis refractory to standard once-daily proton pump inhibitor: the Japan-based EXTEND study. J Gastroenterol. 2018 Jul;53(7):834-844. doi: 10.1007/s00535-017-1417-z. Epub 2017 Nov 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole: 10 mg Twice Daily | Rabeprazole (10 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
| FG001 | Rabeprazole: 20 mg Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Rabeprazole | Drug | Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
|
|
| Rabeprazole | Drug | Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind). |
|
|
| Rabeprazole | Drug | Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). |
|
|
| Weeks 12 and 24 |
| Cumulative Non-recurrence Rate at Week 52 | Non-recurrence rate at Week 52 was estimated using the Kaplan-Meier method. | Week 52 |
| Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of the rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. Heartburn is a burning sensation in the stomach or lower chest; it is worsened by bending or pressure on the abdomen. Heartburn frequency was rated from 0-day (no) to 7-day (always) and severity was graded on a 3-point scale (mild, moderate, severe). Heartburn was evaluated in the daytime (from wake-up time to time for bed) and nighttime (from time for bed to wake-up time). | From Week 4 up to Week 52 |
| Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group shall be performed for participants who did not exhibit daytime or nighttime heartburn at 0 weeks of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared. For the participants who had recurrence, values at the final evaluation were imputed using a last observation carried forward (LOCF) method. | From Week 4 up to Week 52 |
| Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of the rabeprazole (10 mg once daily group) and the rabeprazole (10 mg twice daily group) was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. The presence or absence of heartburn was assessed by the investigators during medical interviews. The heartburn incidence during each of the 7-day periods immediately before visiting the hospital was assessed on a scale of five stages based on the number of days with symptoms: 0 (no symptoms), 1 to 2 (occasional symptoms), 3 to 4 (sometimes had symptoms), 5 to 6 (often had symptoms), and 7 (always had symptoms). The incidence was tabulated by an analysis classifying the states into two groups: "no symptom group" (0 days with symptoms) and "with symptoms group" (1 day or more with symptoms). The severity of heartburn was as below: Mild (feel heartburn but tolerable), Moderate (feel heartburn and hard), and Severe (feel heartburn and terrible). | From Week 4 up to Week 52 |
| Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Sleep disorders during each of the 7-day periods immediately before visiting the hospital were assessed. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). The incidence of sleep disorder was tabulated by an analysis classifying the stages into two groups: "No" (0 days with sleep disorder) and "Yes" (1 or more days with sleep disorder). Heartburn was evaluated prior to 7 days of each visit. | From Week 4 up to Week 52 |
| Frequency of Sleep Disorders During the Maintenance Therapy Period | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). Heartburn was evaluated prior to 7 days of each visit. | From Week 4 up to Week 52 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety was assessed by monitoring and recording all adverse events (AEs) and SAEs, regular monitoring of hematology, clinical chemistry, urine values, and regular measurement of vital signs. All AEs were graded on a 3-point scale; 1) mild was defined as discomfort that did not interfere with normal daily activities, 2) moderate was defined as discomfort that interfered with normal activities, and 3) severe was defined as discomfort that interfered with the ability to work or normal daily activities were impossible. SAEs were medical events that led to death, were life-threatening, required hospitalization or prolongation of hospitalization, caused persistent disability, or resulted in a congenital abnormality. TEAEs were AEs with an onset date on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related AEs were medical events that were considered by the investigator to be possibly or probably related to rabeprazole. | From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days) |
| Inzai |
| Chiba |
| Japan |
| Kamagaya | Chiba | Japan |
| Matsuyama | Ehime | Japan |
| Kitakyushu | Fukuoka | Japan |
| Koga | Fukuoka | Japan |
| Kōriyama | Fukushima | Japan |
| Annaka | Gunma | Japan |
| Fukuyama | Hiroshima | Japan |
| Asahikawa | Hokkaido | Japan |
| Ishikari | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Amagasaki | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya | Hyōgo | Japan |
| Furukawa | Ibaraki | Japan |
| Tsuchiura | Ibaraki | Japan |
| Takamatsu | Kagawa-ken | Japan |
| Ichikikushikino-shi | Kagoshima-ken | Japan |
| Kamakura | Kanagawa | Japan |
| Kawasaki | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Sendai | Miyagi | Japan |
| Suwa | Nagano | Japan |
| Beppu | Oita Prefecture | Japan |
| Fujiidera | Osaka | Japan |
| Hirakata | Osaka | Japan |
| Kishiwada | Osaka | Japan |
| Takatsuki | Osaka | Japan |
| Karatsu | Saga-ken | Japan |
| Ureshino | Saga-ken | Japan |
| Ageo | Saitama | Japan |
| Hiki | Saitama | Japan |
| Toda | Saitama | Japan |
| Wako | Saitama | Japan |
| Izumo | Shimane | Japan |
| Fujieda | Shizuoka | Japan |
| Hamamatsu | Shizuoka | Japan |
| Ōtawara | Tochigi | Japan |
| Adachi City | Tokyo | Japan |
| Bunkyo | Tokyo | Japan |
| Chūō | Tokyo | Japan |
| Koto | Tokyo | Japan |
| Minato | Tokyo | Japan |
| Nerima City | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Shibuya City | Tokyo | Japan |
| Shinagawa | Tokyo | Japan |
| Toshima City | Tokyo | Japan |
| Akita | Japan |
| Fukuoka | Japan |
| Hiroshima | Japan |
| Kochi | Japan |
| Kyoto | Japan |
| Nagasaki | Japan |
| Osaka | Japan |
| Ōita | Japan |
| Saga | Japan |
| Saitama | Japan |
| Yamagata | Japan |
Rabeprazole (20 mg) was administered orally twice daily during the treatment period for 8 weeks (unblinded).
| FG002 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind). |
| FG003 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Rabeprazole 10 mg or 20 mg was administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Therapy Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole: 10 mg Twice Daily | Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
| BG001 | Rabeprazole: 20 mg Twice Daily | Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | 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 | Rate of Non-recurrence at Week 52 | The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. | Central assessment Full Analysis Set (FAS) was defined as all randomized participants who received at least one dose of the study drug, and from whom the results of at least one endoscopic assessment was available. Data analysis excluded participants with missing data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Non-recurrence at Weeks 12 and 24 | The non-recurrence rate (up to 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. The 95% CI was calculated by normal approximation. | Central assessment FAS. Data analysis excluded participants with missing data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 12 and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Non-recurrence Rate at Week 52 | Non-recurrence rate at Week 52 was estimated using the Kaplan-Meier method. | Central assessment FAS | Posted | Number | 95% Confidence Interval | Percentage of non-recurrence | Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of the rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. Heartburn is a burning sensation in the stomach or lower chest; it is worsened by bending or pressure on the abdomen. Heartburn frequency was rated from 0-day (no) to 7-day (always) and severity was graded on a 3-point scale (mild, moderate, severe). Heartburn was evaluated in the daytime (from wake-up time to time for bed) and nighttime (from time for bed to wake-up time). | Central assessment FAS - LOCF. Analysis was carried out on participants who were determined to be free of symptoms at maintenance therapy entry. | Posted | Number | Percentage of participants | From Week 4 up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group shall be performed for participants who did not exhibit daytime or nighttime heartburn at 0 weeks of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared. For the participants who had recurrence, values at the final evaluation were imputed using a last observation carried forward (LOCF) method. | Central assessment FAS | Posted | Number | Percentage of participants | From Week 4 up to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | A comparison of the rabeprazole (10 mg once daily group) and the rabeprazole (10 mg twice daily group) was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. The presence or absence of heartburn was assessed by the investigators during medical interviews. The heartburn incidence during each of the 7-day periods immediately before visiting the hospital was assessed on a scale of five stages based on the number of days with symptoms: 0 (no symptoms), 1 to 2 (occasional symptoms), 3 to 4 (sometimes had symptoms), 5 to 6 (often had symptoms), and 7 (always had symptoms). The incidence was tabulated by an analysis classifying the states into two groups: "no symptom group" (0 days with symptoms) and "with symptoms group" (1 day or more with symptoms). The severity of heartburn was as below: Mild (feel heartburn but tolerable), Moderate (feel heartburn and hard), and Severe (feel heartburn and terrible). | Central assessment FAS - LOCF | Posted | Number | Percentage of participants | From Week 4 up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Sleep disorders during each of the 7-day periods immediately before visiting the hospital were assessed. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). The incidence of sleep disorder was tabulated by an analysis classifying the stages into two groups: "No" (0 days with sleep disorder) and "Yes" (1 or more days with sleep disorder). Heartburn was evaluated prior to 7 days of each visit. | Central assessment FAS. Participants who did not have sleep disorder due to nighttime heartburn or swallowing at the time of maintenance of the Maintenance Therapy Period, participants whose visit data was not missing. | Posted | Number | Percentage of participants | From Week 4 up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Sleep Disorders During the Maintenance Therapy Period | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). Heartburn was evaluated prior to 7 days of each visit. | Central assessment FAS | Posted | Number | Percentage of participants | From Week 4 up to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety was assessed by monitoring and recording all adverse events (AEs) and SAEs, regular monitoring of hematology, clinical chemistry, urine values, and regular measurement of vital signs. All AEs were graded on a 3-point scale; 1) mild was defined as discomfort that did not interfere with normal daily activities, 2) moderate was defined as discomfort that interfered with normal activities, and 3) severe was defined as discomfort that interfered with the ability to work or normal daily activities were impossible. SAEs were medical events that led to death, were life-threatening, required hospitalization or prolongation of hospitalization, caused persistent disability, or resulted in a congenital abnormality. TEAEs were AEs with an onset date on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related AEs were medical events that were considered by the investigator to be possibly or probably related to rabeprazole. | Safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Period and had at least one post-dose safety assessment. | Posted | Count of Participants | Participants | From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days) |
|
From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)
Treatment-emergent adverse events and serious adverse events were reported. The safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Therapy Period and had at least one post-dose safety assessment. All AEs were graded on a 3-point scale (mild, moderate, severe).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rabeprazole: 10 mg Twice Daily | Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). | 0 | 437 | 6 | 437 | 63 | 437 |
| EG001 | Rabeprazole: 20 mg Twice Daily | Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). | 0 | 80 | 4 | 80 | 12 | 80 |
| EG002 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind). | 1 | 178 | 11 | 178 | 75 | 178 |
| EG003 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). | 0 | 181 | 17 | 181 | 87 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Relations Group (EA Pharma Co., Ltd.) | Eisai Co., Ltd. and EA Pharma Co., Ltd. | +81-(0)3-6280-9600 | contact_ea@eapharma.co.jp |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Withdrawal by Subject |
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| Pregnancy |
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| Other |
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| Female |
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| Participants |
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| Participants |
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Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). |
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Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). |
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| Units |
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| Counts |
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| Participants |
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| OG001 | Rabeprazole: 20 mg Twice Daily | Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). |
| OG002 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once daiArm C | Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind). |
| OG003 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind). |
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