Clinical Trial: The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory R
Brief Summary: 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.
Detailed Summary:
Sponsor: Chong Kun Dang Pharmaceutical
Current Primary Outcome: Time to onset of first 1Day Heartburn free, Days [ Time Frame: up to 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Chong Kun Dang Pharmaceutical
Dates:
Date Received: May 20, 2013
Date Started: April 2013
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015
