A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01153659
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 E3810 - 2 Aciphex (rabeprazole) - 3 Nexium (esomeprazole) -
- Primary Outcome Measures
Name Time Method Percentage of time that intragastric pH remains >4 24-hr period post-dose on Day 5
- Secondary Outcome Measures
Name Time Method Percentage of day- and night-time periods with intragastric pH >4 Days 1 and 5 Number and duration of nocturnal acid breakthrough (NAB) episodes Days 1 and 5 Proportion of subjects with nocturnal acid breakthrough (NAB) episodes Days 1 and 5
Trial Locations
- Locations (1)
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States