Trial Outcomes & Findings for An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis (NCT NCT01008696)
NCT ID: NCT01008696
Last Updated: 2013-08-13
Results Overview
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.
COMPLETED
PHASE4
217 participants
Day 57
2013-08-13
Participant Flow
Out of 225 participants consented, 217 were assigned to the study medication.
Participant milestones
| Measure |
Rabeprazole
Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
109
|
|
Overall Study
COMPLETED
|
91
|
92
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Rabeprazole
Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
Overall Study
Participant's evasion of hospital visit
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Participants' non-cooperation
|
2
|
3
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
Baseline characteristics by cohort
| Measure |
Rabeprazole
n=87 Participants
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=91 Participants
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49.70 Years
STANDARD_DEVIATION 11.72 • n=93 Participants
|
49.74 Years
STANDARD_DEVIATION 12.65 • n=4 Participants
|
49.72 Years
STANDARD_DEVIATION 12.17 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 57Population: 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.
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.
Outcome measures
| Measure |
Rabeprazole
n=87 Participants
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=91 Participants
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
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
|
93.94 Percentage of participants
|
|
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
|
100.00 Percentage of participants
|
|
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19
Poor Metabolizer (n=15, 18)
|
93.33 Percentage of participants
|
100.00 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 57Population: 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
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.
Outcome measures
| Measure |
Rabeprazole
n=87 Participants
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=91 Participants
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
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
|
-0.77 Units on a scale
Standard Deviation 0.92
|
|
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
|
-0.20 Units on a scale
Standard Deviation 0.54
|
|
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
|
-0.17 Units on a scale
Standard Deviation 0.55
|
|
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
|
-0.14 Units on a scale
Standard Deviation 0.48
|
|
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 0.80
|
-0.40 Units on a scale
Standard Deviation 0.76
|
|
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
|
-0.37 Units on a scale
Standard Deviation 0.69
|
|
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
|
-0.35 Units on a scale
Standard Deviation 0.74
|
|
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
|
-0.16 Units on a scale
Standard Deviation 0.58
|
|
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
|
-0.11 Units on a scale
Standard Deviation 0.38
|
|
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
|
-0.02 Units on a scale
Standard Deviation 0.15
|
|
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 0.70
|
-0.29 Units on a scale
Standard Deviation 0.54
|
|
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
|
0.59 Units on a scale
Standard Deviation 0.89
|
|
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
|
0.93 Units on a scale
Standard Deviation 0.96
|
|
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
|
0.82 Units on a scale
Standard Deviation 0.78
|
|
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 0.70
|
0.30 Units on a scale
Standard Deviation 0.66
|
|
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 1.00
|
0.94 Units on a scale
Standard Deviation 0.95
|
|
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
|
0.26 Units on a scale
Standard Deviation 0.66
|
|
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
|
0.22 Units on a scale
Standard Deviation 0.54
|
|
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 0.50
|
0.22 Units on a scale
Standard Deviation 0.57
|
|
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
|
0.59 Units on a scale
Standard Deviation 0.80
|
|
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
|
0.44 Units on a scale
Standard Deviation 0.75
|
|
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
|
0.55 Units on a scale
Standard Deviation 0.76
|
|
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
|
0.25 Units on a scale
Standard Deviation 0.55
|
|
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
|
0.13 Units on a scale
Standard Deviation 0.37
|
|
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
|
0.02 Units on a scale
Standard Deviation 0.15
|
|
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 0.70
|
0.36 Units on a scale
Standard Deviation 0.62
|
|
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
|
-0.54 Units on a scale
Standard Deviation 0.90
|
|
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
|
-0.84 Units on a scale
Standard Deviation 0.95
|
|
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
|
-0.32 Units on a scale
Standard Deviation 0.66
|
|
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
|
-0.21 Units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Day 57Population: 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.
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.
Outcome measures
| Measure |
Rabeprazole
n=84 Participants
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=89 Participants
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
Overall Assessment of Study Medication by Investigator
|
1.37 Units on a scale
Standard Deviation 0.71
|
1.43 Units on a scale
Standard Deviation 0.74
|
Adverse Events
Rabeprazole
Lansoprazole
Serious adverse events
| Measure |
Rabeprazole
n=108 participants at risk
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=109 participants at risk
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.93%
1/108 • Baseline up to Day 57
|
0.00%
0/109 • Baseline up to Day 57
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.93%
1/108 • Baseline up to Day 57
|
0.00%
0/109 • Baseline up to Day 57
|
Other adverse events
| Measure |
Rabeprazole
n=108 participants at risk
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
|
Lansoprazole
n=109 participants at risk
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
17.6%
19/108 • Baseline up to Day 57
|
16.5%
18/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
12/108 • Baseline up to Day 57
|
15.6%
17/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
10/108 • Baseline up to Day 57
|
13.8%
15/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
9/108 • Baseline up to Day 57
|
11.0%
12/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Dysphagia
|
9.3%
10/108 • Baseline up to Day 57
|
9.2%
10/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Nausea
|
7.4%
8/108 • Baseline up to Day 57
|
8.3%
9/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Regurgitation
|
2.8%
3/108 • Baseline up to Day 57
|
3.7%
4/109 • Baseline up to Day 57
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/108 • Baseline up to Day 57
|
0.00%
0/109 • Baseline up to Day 57
|
|
General disorders
Sensation of foreign body
|
12.0%
13/108 • Baseline up to Day 57
|
14.7%
16/109 • Baseline up to Day 57
|
|
General disorders
Early satiety
|
10.2%
11/108 • Baseline up to Day 57
|
10.1%
11/109 • Baseline up to Day 57
|
|
General disorders
Non-cardiac chest pain
|
5.6%
6/108 • Baseline up to Day 57
|
3.7%
4/109 • Baseline up to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
18/108 • Baseline up to Day 57
|
13.8%
15/109 • Baseline up to Day 57
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
9/108 • Baseline up to Day 57
|
8.3%
9/109 • Baseline up to Day 57
|
Additional Information
Clinical Research Associate
Medical Affairs, Seoul, Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place