reflux esophagitis
Conditions
Interventions
Esomeprazole magnesium hydrate, 20 mg, once daily, 4 weeks (oral capsule)
Lansoprazole, 30 mg, once daily, 4 weeks (oral capsule or oral disintegrating tablet)
Sponsors
Research Organization for Gastroenterological Disease Treatment
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 20 years or older at the time of providing informed consent. (2) Patients who were diagnosed with erosive reflux esophagitis (Los Angeles Classification grade A or severer) by endoscopy. (3) Patients who have been on continuing treatment with rabeprazole 10 mg once daily for at least 4 weeks for reflux esophagitis. (4) Patients who had moderate or severe reflux symptoms for at least 1 day or mild reflux symptoms for at least 2 days during the 1 week prior to eligibility check. Specifically, patients whose answers to a Symptom Questionnaire at the time of eligibility check should meet either of the following criteria: (i) The presence of heartburn or acid reflux for 1 day during the past 1 week and a Global Overall Symptom scale (GOS) score of 4 or higher for either heartburn (Question (ii)) or acid reflux (Question (iii)). (ii) The presence of heartburn or acid reflux for at least 2 days during the past 1 week and a score of 3 or higher for either heartburn (Question (ii)) or acid reflux (Question (iii)). (5) Patients who have received complete information about the study and are willing to provide voluntary written consent prior to enrollment in the study.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to the study drugs. (2) Patients with a history of digestive tract resection or vagotomy. (3) Patients with warning findings such as vomiting, gastrointestinal hemorrhage (including findings such as hematemesis, melena, and anemia) and acute weight loss. (4) Patients with concurrent peptic ulcer (excluding the scarred stage). (5) Patients with a past or current history of any of the following diseases: Zollinger-Ellison syndrome, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), esophageal stenosis, esophageal achalasia, malabsorption, or cerebrovascular disorder such as cerebral hemorrhage and cerebral infarction. (6) Patients treated for H. pylori eradication within 6 months before the time of eligibility check. (7) Patients who may have difficulty participating in the study owing to serious complications such as liver, renal, or cardiac diseases. (8) Patients with a confirmed or possible malignancy. (9) Women who are pregnant, lactating, or possibly pregnant. (10) Patients who are on proton pump inhibitors other than lansoprazole. (11) Patients who need to continue treatment with drugs for which interactions with the study drugs are anticipated. (12) Patients who are on or need to continue treatment with drugs that are assumed to have an effect on study results. *However, patients may be enrolled in the study if such drugs are interrupted for 1 week prior to the investigation of the symptoms or are switched to other treatment. (13) Patients who are determined by the investigator or subinvestigator to be not suitable to be enrolled in the study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the number of days the patient reported reflux symptoms (heartburn or acid reflux) from the baseline to that during the 1-week period immediately before Week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The number of days the patient reported reflux symptoms during the 1-week period immediately before Week 2. (2) Resolution rate of reflux symptoms (The proportion of patients who do not report reflux symptoms during the 1-week period immediately before Week 2 or 4). (3) Remission rate of reflux symptoms (The proportion of patients who do not report reflux symptoms during the 1-week period immediately before Week 2 or 4 or who have mild reflux symptoms [GOS score of 2] for only 1 day during the 1-week period immediately before Week 2 or 4). (4) Number of day(s) to sustained resolution of reflux symptom (7 constitutive days without reflux symptom in the symptom diary). (5) Number of day(s) to sustained remission of reflux symptom (7 constitutive days without reflux symptom or with mild reflux symptom on only-1 day, as recorded in the symptom diary). (6) The change in the GOS upper abdominal symptom score from the baseline to that during the 1-week period immediately before Week 2 or 4. (7) Reflux symptom score (based on the Symptom Diary) on each day from the following day of study treatment initiation to Week 2. (8) Factors (e.g., sex, age, BMI, presence or absence of H. pylori infection, lifestyle habits, and comorbidities), which may affect the frequency, resolution, and remission of reflux symptoms. | — |
Countries
Japan
Outcome results
None listed