A Phase 3 interventional study of Ilaprazole in Non-erosive Reflux Disease, sponsored by Il-Yang Pharm. Co., Ltd.. Completed at 11 sites in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Treatment
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
Diagnosed with non-erosive reflux disease meeting all of the following criteria:
2-1) At least either heartburn or acid regurgitation has persisted for at least past 3 months before screening 2-2) Have experienced at least either heartburn or acid regurgitation of moderate or higher intensity on at least 2 days of 7 days prior to initiation of the investigational product 2-3) Esophageal mucosal breaks by LA Classification are not observed on upper gastrointestinal endoscopy at screening
Exclusion Criteria:
Abnormal value on laboratory test at screening:
3-1) Total Bilirubin, Creatinine > Upper limit of normal (ULN) x 1.5 3-2) Alkaline Phosphatase, BUN > ULN x 2
10mg Ilaprazole x 2 tablets
Drug: Ilaprazole
10mg placebo of Ilaprazole x 2 tablets
Drug: Ilaprazole
10mgx2 tablet once daily for weeks
Also known as: IY81149
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)
Plan to share: No — IPD will not be shared to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Il-Yang Pharm. Co., Ltd.