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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03444883
Other study ID # IL49NE03
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 31, 2018
Est. completion date February 25, 2020

Study information

Verified date December 2020
Source Il-Yang Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ilaprazole
10mgx2 tablet once daily for weeks

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Sponsors (1)

Lead Sponsor Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks(28 days)
Secondary 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. 4 weeks(28 days)
Secondary 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 4 weeks(28 days)
Secondary 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. 4 weeks(28 days)
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