Erosive Esophagitis
Conditions
Brief summary
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
Interventions
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification
Exclusion criteria
* Gastric or duodenal ulcers (excluding ulcer scars) * Concurrent presence of Barrett's esophagus * A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks * Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Rates of Reflux Esophagitis | 8 weeks | Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Days Without 'Cardinal Symptom' | 4 or 8 week | The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain |
| The Proportion of Daytimes Without 'Cardinal Symptom' | 4 or 8 week | The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain |
| The Proportion of Nighttimes Without 'Cardinal Symptom' | 4 or 8 week | The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lafutidine Lafutidine 20mg/day
Lafutidine: Lafutidine 20mg/day | 165 |
| Famotidine Famotidine 40mg/day
Famotidine: Famotidine 40mg/day | 162 |
| Omeprazole Omeprazole 20mg/day
Omeprazole: Omeprazole 20mg/day | 167 |
| Total | 494 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 | 2 |
| Overall Study | Deviation from visit window | 0 | 0 | 1 |
| Overall Study | Did not meet I/E criteria | 8 | 4 | 4 |
| Overall Study | Error of Prescriptions | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 | 5 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Prohibited Concomitant medication | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 10 | 8 |
Baseline characteristics
| Characteristic | Lafutidine | Famotidine | Omeprazole | Total |
|---|---|---|---|---|
| Age, Continuous Age, Mean+-STD (years) | 50.20 years STANDARD_DEVIATION 13.57 | 51.25 years STANDARD_DEVIATION 12.76 | 49.65 years STANDARD_DEVIATION 13.84 | 50.36 years STANDARD_DEVIATION 13.39 |
| Age, Continuous | 53.00 years | 53.00 years | 50.00 years | 52.00 years |
| Age, Customized 20 years~ 29 years | 18 Participants | 10 Participants | 16 Participants | 44 Participants |
| Age, Customized 30 years ~ 39 years | 22 Participants | 23 Participants | 30 Participants | 75 Participants |
| Age, Customized 40 years ~ 49 years | 25 Participants | 30 Participants | 32 Participants | 87 Participants |
| Age, Customized 50 years ~ 59 years | 55 Participants | 49 Participants | 41 Participants | 145 Participants |
| Age, Customized 60 years ~ 69 years | 36 Participants | 40 Participants | 37 Participants | 113 Participants |
| Age, Customized 70 years ~ 74 years | 9 Participants | 10 Participants | 11 Participants | 30 Participants |
| Sex: Female, Male Female | 60 Participants | 48 Participants | 46 Participants | 154 Participants |
| Sex: Female, Male Male | 105 Participants | 114 Participants | 121 Participants | 340 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 165 | 30 / 162 | 34 / 167 |
| serious Total, serious adverse events | 0 / 165 | 0 / 162 | 3 / 167 |
Outcome results
Primary
Recovery Rates of Reflux Esophagitis
Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
Time frame: 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lafutidine | Recovery Rates of Reflux Esophagitis | Recovered | 101 Participants |
| Lafutidine | Recovery Rates of Reflux Esophagitis | Not recovered | 43 Participants |
| Famotidine | Recovery Rates of Reflux Esophagitis | Recovered | 92 Participants |
| Famotidine | Recovery Rates of Reflux Esophagitis | Not recovered | 53 Participants |
| Omeprazole | Recovery Rates of Reflux Esophagitis | Recovered | 126 Participants |
| Omeprazole | Recovery Rates of Reflux Esophagitis | Not recovered | 21 Participants |
p-value: 0.05Chi-squared
Secondary
The Proportion of Days Without 'Cardinal Symptom'
The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain
Time frame: 4 or 8 week
Population: Missing = Lafutidine(5) , Omeprazole(1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lafutidine | The Proportion of Days Without 'Cardinal Symptom' | week 8 | 0.77 proportion of days | Standard Deviation 0.27 |
| Lafutidine | The Proportion of Days Without 'Cardinal Symptom' | week 4 | 0.64 proportion of days | Standard Deviation 0.31 |
| Lafutidine | The Proportion of Days Without 'Cardinal Symptom' | week 8(LOCF) | 0.77 proportion of days | Standard Deviation 0.27 |
| Famotidine | The Proportion of Days Without 'Cardinal Symptom' | week 8 | 0.67 proportion of days | Standard Deviation 0.32 |
| Famotidine | The Proportion of Days Without 'Cardinal Symptom' | week 4 | 0.56 proportion of days | Standard Deviation 0.32 |
| Famotidine | The Proportion of Days Without 'Cardinal Symptom' | week 8(LOCF) | 0.67 proportion of days | Standard Deviation 0.32 |
| Omeprazole | The Proportion of Days Without 'Cardinal Symptom' | week 4 | 0.69 proportion of days | Standard Deviation 0.3 |
| Omeprazole | The Proportion of Days Without 'Cardinal Symptom' | week 8(LOCF) | 0.82 proportion of days | Standard Deviation 0.24 |
| Omeprazole | The Proportion of Days Without 'Cardinal Symptom' | week 8 | 0.82 proportion of days | Standard Deviation 0.24 |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
The Proportion of Daytimes Without 'Cardinal Symptom'
The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Time frame: 4 or 8 week
Population: Missing = Lafutidine(5) , Omeprazole(1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lafutidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8 | 0.83 proportion of days | Standard Deviation 0.23 |
| Lafutidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 4 | 0.74 proportion of days | Standard Deviation 0.27 |
| Lafutidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.83 proportion of days | Standard Deviation 0.23 |
| Famotidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8 | 0.76 proportion of days | Standard Deviation 0.28 |
| Famotidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 4 | 0.68 proportion of days | Standard Deviation 0.29 |
| Famotidine | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.76 proportion of days | Standard Deviation 0.28 |
| Omeprazole | The Proportion of Daytimes Without 'Cardinal Symptom' | week 4 | 0.77 proportion of days | Standard Deviation 0.27 |
| Omeprazole | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.87 proportion of days | Standard Deviation 0.2 |
| Omeprazole | The Proportion of Daytimes Without 'Cardinal Symptom' | week 8 | 0.87 proportion of days | Standard Deviation 0.2 |
Secondary
The Proportion of Nighttimes Without 'Cardinal Symptom'
The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Time frame: 4 or 8 week
Population: Missing = Lafutidine(5) , Omeprazole(1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lafutidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8 | 0.87 proportion of days | Standard Deviation 0.19 |
| Lafutidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 4 | 0.75 proportion of days | Standard Deviation 0.27 |
| Lafutidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.87 proportion of days | Standard Deviation 0.19 |
| Famotidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8 | 0.78 proportion of days | Standard Deviation 0.29 |
| Famotidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.78 proportion of days | Standard Deviation 0.29 |
| Famotidine | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 4 | 0.72 proportion of days | Standard Deviation 0.3 |
| Omeprazole | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 4 | 0.82 proportion of days | Standard Deviation 0.23 |
| Omeprazole | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8(LOCF) | 0.89 proportion of days | Standard Deviation 0.18 |
| Omeprazole | The Proportion of Nighttimes Without 'Cardinal Symptom' | week 8 | 0.89 proportion of days | Standard Deviation 0.18 |