Erosive Esophagitis
Conditions
Brief summary
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Detailed description
Patients: Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis. Outcome parameters: The main outcome measures 1. Rate of complete symptom relief (CSR) at the end of initial treatment phase 2. rate of symptom relapse within 12 weeks after stopping initial therapy
Interventions
Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients between the ages of 15 and 80 years * with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, * who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.
Exclusion criteria
1. coexistence of peptic ulcer or gastrointestinal malignancies, 2. pregnancy, 3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), 4. previous gastric surgery, 5. allergy to esomeprazole, 6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and 7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rates of Complete Symptom Relief | at the 20 weeks after the end of initial treatment. | Rate of complete symptom relief (CSR) at the end of initial treatment phase |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4-week Group Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis | 207 |
| 8-week Group Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily
Esomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis | 201 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incomplete symptom resolution | 45 | 35 |
| Overall Study | Lost to Follow-up | 10 | 9 |
Baseline characteristics
| Characteristic | 4-week Group | 8-week Group | Total |
|---|---|---|---|
| Age, Continuous age | 51.1 years STANDARD_DEVIATION 12.8 | 51.1 years STANDARD_DEVIATION 12.8 | 51.1 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment Taiwan | 207 Participants | 201 Participants | 408 Participants |
| Sex: Female, Male sex Female | 87 Participants | 77 Participants | 164 Participants |
| Sex: Female, Male sex Male | 120 Participants | 124 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 207 | 0 / 201 |
| other Total, other adverse events | 0 / 207 | 0 / 201 |
| serious Total, serious adverse events | 0 / 207 | 0 / 201 |
Outcome results
Primary
The Rates of Complete Symptom Relief
Rate of complete symptom relief (CSR) at the end of initial treatment phase
Time frame: at the 20 weeks after the end of initial treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4 Week Group | The Rates of Complete Symptom Relief | 152 participants |
| 8 Week Group | The Rates of Complete Symptom Relief | 157 participants |
p-value: <0.05Chi-squared