continuous versus on demand maintennace treatment with a proton pump inhibitor in patients with non-erosive gastroesophageal reflux disease or mild erosive esophagitis

A randomized, multicenter study: continuous versus on demand maintennace treatment with a proton pump inhibitor in patients with non-erosive gastroesophageal reflux disease or mild erosive esophagitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005281

Enrollment

414

Registered

2020-08-04

Start date

2020-09-15

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : (Continuous treatment) 20mg Pantoprazol is oral medication once a day (On-demand treatment) 20mg Pantoprazol is oral medication once a day(within 4 days if symptoms are present), and if symptom

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patient aged over 19 years and under 75 years at the time of consent provide 2)Patient with a history of non-erosive gastroesophageal reflux disease or mild erosive esophagitis(LA grade A, B) by gastroscopy within 12 weeks 3)Patient who can understand and follow the clinical trial: procedure and visit peiod 4)Patient who had voluntarily decided participation, and provided written consent

Exclusion criteria

Exclusion criteria: 1)Patient with esophageal stricture, esophageal varix, Barrett's esophagus(over 3cm), peptic ulcer, gastrointestinal bleeding, malignant tumor, eosionophilic esophagitis 2)Patient with primary esophageal motility disorder 3)Patient with surgery related to gastroesophageal 4)Patient who has hypersensitivity reaction of antacid agen, PPI 5)Patient with a history of malignant tumor within the last 5 years 6)Patient who has significant disease with liver, kidney, cardiac, respiratory, endocrine, central nervous system 7)Patient with abnormal result of AST,ALT,Serum Creatinine>X2 of Normal lab range 8)Pregnant or breast-feeding women 9)Patient with a history of phsychiatric disease within the last 5 years 10)Patient with planned operation during the clinical trial 11)Subject who has any clinically meaningful disease in investigator's judgement to prevent participating in this study

Design outcomes

Primary

Measure	Time frame
Safety(Adverse Events, Serious Adverse Events);unwillingness to continue rate within maintenance treatment	—

Secondary

Measure	Time frame
change rate of total score	—

Countries

Korea, Republic of

Contacts

Public ContactDH Jung

Yonsei University Health System, Severance Hospital

jungdh@yuhs.ac+82-2-2228-5170

Outcome results