The purpose of this study is to evaluate the efficacy and safety of Ilaprazole 20 mg in patients with non-erosive reflux disease. This study intends to demonstrate the clinical superiority of Ilaprazole 20 mg to placebo administered once daily for 4 weeks.
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
277
10mgx2 tablet once daily for weeks
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, South Korea
Inje University Busan Paik Hospital
Busan, Busanjin-gu, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu, South Korea
Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose
Percentage of subjects who were assessed as having 'lost' the frequency and intensity of typical esophagitis symptoms by RDQ assessment at 4 weeks of treatment
Time frame: 4 weeks(28 days)
Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose
The mean scores for esophagitis symptom (heartburn and/or acid regurgitation) frequency and intensity assessed with RDQ (Questions a, b/c, d) and the change in mean score across both domains.
Time frame: 4 weeks(28 days)
Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose
The change in mean score for quality of life assessed with PAGI-QoL
Time frame: 4 weeks(28 days)
Change in esophagitis symptom score according to the maximum number of rescue medication doses per day
The mean scores for esophagitis symptom (heartburn and/or acid regurgitation) frequency and intensity assessed with RDQ (Questions a, b/c, d) at 4 weeks of treatment versus pre-dose according to the maximum number of rescue medication doses per day and the change in mean score across both domains.
Time frame: 4 weeks(28 days)
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Chonbuk National University Hospital
Jeonju, Jeonju-si, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University
Seoul, Jongno-gu, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Inje University Seoul Paik Hospital
Seoul, Jung-gu, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seodaemun-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Soon Chun Hyang University Hospital, Buchon
Bucheon-si, Wonmi-gu, South Korea
...and 1 more locations