A Phase 4 interventional study of Newrabell® Tablet 10mg in Reflux Esophagitis, sponsored by Chong Kun Dang Pharmaceutical. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-09-24.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.
322 studies on the registry are indexed under Esophagitis; 38 are open to participants now.
This study's enrollment of 39 is below the median of 66 across 215 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Refractory reflux esophagitis to PPIs standard treatment as follows
Exclusion Criteria:
The following medical history
Severe medical disease that needs these prohibited medication
Newrabell® Tablet 10mg b.i.d PO during 8 weeks
Drug: Newrabell® Tablet 10mg
Also known as: Rabeprazole sodium
Time to onset of first 1Day Heartburn free, Days
Time frame: up to 8 weeks
Time to onset of first 2Days Heartburn free, Days
Time frame: up to 8 weeks
1Day Heartburn free days, %
Time frame: up to 8 weeks
Time in Daytime of first Heartburn free, Days
Time frame: up to 8 weeks
Time in Nighttime of first Heartburn free, Days
Time frame: up to 8 weeks
Weekly Heartburn Improvement Rate, %
Time frame: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W4
Time frame: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W8
Time frame: up to 8 weeks
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Chong Kun Dang Pharmaceutical