Reflux Esophagitis
Conditions
Keywords
Reflux esophagitis, Rabeprazole, Lansoprazole
Brief summary
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.
Detailed description
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.
Interventions
DRUGRabeprazole
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.
DRUGLansoprazole
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with reflux esophagitis of Grade A or higher by Los Angeles (LA) classification based on the endoscopy among participants complaining of gastroesophageal reflux symptoms (such as: Heartburn, regurgitation, globus sensation, chronic \[lasting a long time\] cough \[sudden, loud flow if air from the lungs\], epigastric \[area above the navel\] pain, non-cardiac chest pain, hoarseness, or dysphagia), or those who diagnosed with reflux esophagitis of Grade B or higher without complaining of symptoms * Participants without other serious disease except the study indication (reflux esophagitis) * Participants with hematology (related to blood) panel, serum chemistry panel, or urinalysis result clinically within twice the normal range * Female Participants of child-bearing potential who are using the appropriate contraceptive or with a negative urine pregnancy test
Exclusion criteria
* Participants with other serious gastrointestinal disease except reflux esophagitis (example: digestive tract cancer \[abnormal tissue that grows and spreads in the body until it kills\], hepatic disease, pancreatic disease, and ulcer. However, the scar of an ulcer is included in study targets * Participants with other serious concomitant disease(s) such as renal disorder, cerebrovascular disease, cardiovascular disease, hepatic disease, and severe respiratory disease * Participants with medical history of upper gastrointestinal tract surgery, esophagostenosis, or a chalasia * Participants with hematology panel, serum chemistry panel, or urinalysis result of above twice the normal range * Participants who cannot discontinue proton pump inhibitors or Histamine 2 antagonist which may have influence on the study, 4 weeks before the start of this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Day 57 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline and Day 57 | 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. |
| Overall Assessment of Study Medication by Investigator | Day 57 | 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. |
Participant flow
Pre-assignment details
Out of 225 participants consented, 217 were assigned to the study medication.
Participants by arm
| Arm | Count |
|---|---|
| Rabeprazole Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days | 87 |
| Lansoprazole Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days | 91 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Other | 2 | 3 |
| Overall Study | Participant's evasion of hospital visit | 5 | 4 |
| Overall Study | Participants' non-cooperation | 2 | 3 |
| Overall Study | Physician Decision | 5 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Rabeprazole | Lansoprazole | Total |
|---|---|---|---|
| Age Continuous | 49.70 Years STANDARD_DEVIATION 11.72 | 49.74 Years STANDARD_DEVIATION 12.65 | 49.72 Years STANDARD_DEVIATION 12.17 |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 34 Participants |
| Sex: Female, Male Male | 75 Participants | 69 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 108 | 42 / 109 |
| serious Total, serious adverse events | 2 / 108 | 0 / 109 |
Outcome results
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rabeprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Poor Metabolizer (n=15, 18) | 93.33 Percentage of participants |
| Rabeprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Homozygous Extensive Metabolizer (n=42, 35) | 97.37 Percentage of participants |
| Rabeprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Heterozygous Extensive Metabolizer (n=30, 38) | 100.00 Percentage of participants |
| Lansoprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Homozygous Extensive Metabolizer (n=42, 35) | 93.94 Percentage of participants |
| Lansoprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Heterozygous Extensive Metabolizer (n=30, 38) | 100.00 Percentage of participants |
| Lansoprazole | Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19 | Poor Metabolizer (n=15, 18) | 100.00 Percentage of participants |
p-value: 0.8849Chi-squared
p-value: 0.865Chi-squared
p-value: 0.266Chi-squared
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.
Time frame: Baseline and Day 57
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Vomiting (n=87, 91) | 0.08 Units on a scale | Standard Deviation 0.38 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Epigastric pain (n=87, 90) | 0.91 Units on a scale | Standard Deviation 1 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Belching (n=87, 91) | 0.38 Units on a scale | Standard Deviation 0.7 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Bloating (n=87, 90) | 0.55 Units on a scale | Standard Deviation 0.82 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Non cardiac chest pain (n=85, 90) | 0.33 Units on a scale | Standard Deviation 0.71 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Regurgitation (n=87, 91) | -0.89 Units on a scale | Standard Deviation 0.93 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Vomiting (n=87, 91) | -0.08 Units on a scale | Standard Deviation 0.38 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Globus sensation (n=87, 91) | -0.31 Units on a scale | Standard Deviation 0.69 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Hoarseness (n=87, 90) | 0.23 Units on a scale | Standard Deviation 0.54 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Chronic cough (n=87, 91) | -0.22 Units on a scale | Standard Deviation 0.64 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Dysphagia (n=87, 91) | 0.16 Units on a scale | Standard Deviation 0.5 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Epigastric pain (n=87, 90) | -0.77 Units on a scale | Standard Deviation 0.95 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline:Regurgitation (n=87, 91) | 0.98 Units on a scale | Standard Deviation 0.93 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57:Non cardiac chest pain (n=85, 90) | -0.28 Units on a scale | Standard Deviation 0.65 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Abdominal distension (n=87, 91) | 0.61 Units on a scale | Standard Deviation 0.84 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Hoarseness (n=87, 90) | -0.14 Units on a scale | Standard Deviation 0.51 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Globus sensation (n=87, 91) | 0.55 Units on a scale | Standard Deviation 0.82 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Abdominal distension (n=87, 91) | -0.38 Units on a scale | Standard Deviation 0.8 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Heartburn (n=87, 91) | -0.55 Units on a scale | Standard Deviation 0.83 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Bloating (n=87, 90) | -0.41 Units on a scale | Standard Deviation 0.72 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Post-prandial discomfort (n=87, 91) | 0.53 Units on a scale | Standard Deviation 0.78 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day57:Post-prandial discomfort (n=87,91) | -0.45 Units on a scale | Standard Deviation 0.73 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Chronic cough (n=87, 91) | 0.34 Units on a scale | Standard Deviation 0.7 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Early satiety (n=86, 91) | -0.21 Units on a scale | Standard Deviation 0.49 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Early satiety (n=86, 91) | 0.27 Units on a scale | Standard Deviation 0.58 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Nausea (n=87, 91) | -0.16 Units on a scale | Standard Deviation 0.48 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Dysphagia (n=87, 91) | -0.11 Units on a scale | Standard Deviation 0.44 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Nausea (n=87, 91) | 0.16 Units on a scale | Standard Deviation 0.48 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Belching (n=87, 91) | -0.25 Units on a scale | Standard Deviation 0.7 |
| Rabeprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Heartburn (n=87, 91) | 0.61 Units on a scale | Standard Deviation 0.84 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Belching (n=87, 91) | -0.29 Units on a scale | Standard Deviation 0.54 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline:Regurgitation (n=87, 91) | 0.93 Units on a scale | Standard Deviation 0.96 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Nausea (n=87, 91) | 0.13 Units on a scale | Standard Deviation 0.37 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Dysphagia (n=87, 91) | -0.14 Units on a scale | Standard Deviation 0.48 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Heartburn (n=87, 91) | 0.59 Units on a scale | Standard Deviation 0.89 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Globus sensation (n=87, 91) | 0.82 Units on a scale | Standard Deviation 0.78 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Chronic cough (n=87, 91) | 0.30 Units on a scale | Standard Deviation 0.66 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Epigastric pain (n=87, 90) | 0.94 Units on a scale | Standard Deviation 0.95 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Non cardiac chest pain (n=85, 90) | 0.26 Units on a scale | Standard Deviation 0.66 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Hoarseness (n=87, 90) | 0.22 Units on a scale | Standard Deviation 0.54 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Dysphagia (n=87, 91) | 0.22 Units on a scale | Standard Deviation 0.57 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Abdominal distension (n=87, 91) | 0.59 Units on a scale | Standard Deviation 0.8 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Bloating (n=87, 90) | 0.44 Units on a scale | Standard Deviation 0.75 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Post-prandial discomfort (n=87, 91) | 0.55 Units on a scale | Standard Deviation 0.76 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Early satiety (n=86, 91) | 0.25 Units on a scale | Standard Deviation 0.55 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Vomiting (n=87, 91) | 0.02 Units on a scale | Standard Deviation 0.15 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Baseline: Belching (n=87, 91) | 0.36 Units on a scale | Standard Deviation 0.62 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Heartburn (n=87, 91) | -0.54 Units on a scale | Standard Deviation 0.9 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Regurgitation (n=87, 91) | -0.84 Units on a scale | Standard Deviation 0.95 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Globus sensation (n=87, 91) | -0.32 Units on a scale | Standard Deviation 0.66 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Chronic cough (n=87, 91) | -0.21 Units on a scale | Standard Deviation 0.61 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Epigastric pain (n=87, 90) | -0.77 Units on a scale | Standard Deviation 0.92 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57:Non cardiac chest pain (n=85, 90) | -0.20 Units on a scale | Standard Deviation 0.54 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Hoarseness (n=87, 90) | -0.17 Units on a scale | Standard Deviation 0.55 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Abdominal distension (n=87, 91) | -0.40 Units on a scale | Standard Deviation 0.76 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Bloating (n=87, 90) | -0.37 Units on a scale | Standard Deviation 0.69 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day57:Post-prandial discomfort (n=87,91) | -0.35 Units on a scale | Standard Deviation 0.74 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Early satiety (n=86, 91) | -0.16 Units on a scale | Standard Deviation 0.58 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Nausea (n=87, 91) | -0.11 Units on a scale | Standard Deviation 0.38 |
| Lansoprazole | Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire | Change at Day 57: Vomiting (n=87, 91) | -0.02 Units on a scale | Standard Deviation 0.15 |
p-value: 0.7734Wilcoxon rank-sum test
p-value: 0.6414Wilcoxon rank-sum test
p-value: 0.7809Wilcoxon rank-sum test
p-value: 0.8294Wilcoxon rank-sum test
p-value: 0.9874Wilcoxon rank-sum test
p-value: 0.2776Wilcoxon rank-sum test
p-value: 0.6295Wilcoxon rank-sum test
p-value: 0.5335Wilcoxon rank-sum test
p-value: 0.8068Wilcoxon rank-sum test
p-value: 0.568Wilcoxon rank-sum test
p-value: 0.5913Wilcoxon rank-sum test
p-value: 0.5566Wilcoxon rank-sum test
p-value: 0.7047Wilcoxon rank-sum test
p-value: 0.3654Wilcoxon rank-sum test
p-value: 0.531Wilcoxon rank-sum test
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rabeprazole | Overall Assessment of Study Medication by Investigator | 1.37 Units on a scale | Standard Deviation 0.71 |
| Lansoprazole | Overall Assessment of Study Medication by Investigator | 1.43 Units on a scale | Standard Deviation 0.74 |
p-value: 0.5032Wilcoxon rank-sum test