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| ID | Type | Description | Link |
|---|---|---|---|
| RAB-KOR-4023 |
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The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end which is passed down your throat into the esophagus, stomach, and duodenum) after treatment with rabeprazole and lansoprazole.
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), randomized (study drug assigned by chance) study in participants with reflux esophagitis. The study will include 4 visits: Visit 1 (Screening period of up to 14 days), Visit 2 (Day 1), Visit 3 (Day 29+3), and Visit 4 (Day 56). After Screening, eligible participants will be analyzed on Visit 2 (Day 1) for symptoms during past week, At visit 3 (Day 29+3) participants will be randomly assigned to 1 of the 2 treatment groups: rabeprazole 20 milligram (mg) or lansoprazole 30 mg group. Participants will receive rabeprazole 20 mg tablet orally once daily for 28 to 56 days or lansoprazole 30 mg capsule orally once daily for 28 to 56 days. A post-study follow-up visit will be conducted only if participant will be affected by any serious adverse event within 30 days after the completion of study drug. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 2 groups. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazole | Experimental | Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. |
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| Lansoprazole | Active Comparator | Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole | Drug | Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers. | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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Out of 225 participants consented, 217 were assigned to the study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole | Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days |
| FG001 | Lansoprazole | Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lansoprazole | Drug | Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days. |
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| Baseline and Day 57 |
| Overall Assessment of Study Medication by Investigator | Investigator's overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad. | Day 57 |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were measured for full analysis set (FAS) population. It included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole | Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days |
| BG001 | Lansoprazole | Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age continuous was measured for full analysis set (FAS) population. It included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibilitycriteria. Last observation carried forward (LOCF) was used. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Gender is measured for the FAS popluation. It included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibilitycriteria. Last observation carried forward (LOCF) was used. | Count of Participants | 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 | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers. | The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure. | Posted | Number | Percentage of participants | Day 57 |
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| Secondary | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping. | The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 57 |
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| Secondary | Overall Assessment of Study Medication by Investigator | Investigator's overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad. | The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Day 57 |
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Baseline up to Day 57
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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 | Rabeprazole | Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days | 2 | 108 | 42 | 108 | ||
| EG001 | Lansoprazole | Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days | 0 | 109 | 42 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Haemorrhoid operation | Surgical and medical procedures | MedDRA V 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Regurgitation | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Early satiety | General disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA V 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Medical Affairs, Seoul, Korea | 82-2-2094-4835 |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D064747 | Lansoprazole |
| 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 |
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| Poor Metabolizer (n=15, 18) |
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Heterozygous extensive metabolizer |
| No |
| Superiority or Other |
| Chi-squared | 0.2660 | Poor metabolizer | No | Superiority or Other |
| Units | Counts |
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| Participants |
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