Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.|
- The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Experimental: Ilaprazole 5 mg QD||
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
|Experimental: Ilaprazole 20 mg QD||
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
|Experimental: Ilaprazole 40 mg QD||
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
|Active Comparator: Lansoprazole 30 mg QD||
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.
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|Study Director:||Medical Director||Takeda|