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

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01153659

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

29.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: E3810 Drug: Aciphex (rabeprazole) Drug: Nexium (esomeprazole)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: E3810 RAB ER 50 mg capsule once per day on Days 1-5
Active Comparator: 2	Drug: Aciphex (rabeprazole) Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
Active Comparator: 3	Drug: Nexium (esomeprazole) Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Arm

Intervention/Treatment

Experimental: 1

Drug: E3810

RAB ER 50 mg capsule once per day on Days 1-5

Active Comparator: 2

Drug: Aciphex (rabeprazole)

Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5

Active Comparator: 3

Drug: Nexium (esomeprazole)

Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5

Outcome Measures

Primary Outcome Measures

Percentage of time that intragastric pH remains >4 [24-hr period post-dose on Day 5]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key inclusion:

Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)

Key Exclusion:

Subjects who are H. pylori-positive
Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
Other standard clinical pharmacology exclusion criteria for healthy volunteers