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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01153659
First received: June 28, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Healthy
Drug: E3810
Drug: Aciphex (rabeprazole)
Drug: Nexium (esomeprazole)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Percentage of time that intragastric pH remains >4 [ Time Frame: 24-hr period post-dose on Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of day- and night-time periods with intragastric pH >4 [ Time Frame: Days 1 and 5 ] [ Designated as safety issue: No ]
  • Number and duration of nocturnal acid breakthrough (NAB) episodes [ Time Frame: Days 1 and 5 ] [ Designated as safety issue: No ]
  • Proportion of subjects with nocturnal acid breakthrough (NAB) episodes [ Time Frame: Days 1 and 5 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153659

Locations
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Philip Miner Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01153659     History of Changes
Other Study ID Numbers: E3810-A001-038
Study First Received: June 28, 2010
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
rabeprazole
esomeprazole
h. pylori-negative
nocturnal acid breakthrough
intragastric pH, PK/PD
effect on gastric pH in healthy, H. pylori-Negative subjects

Additional relevant MeSH terms:
Rabeprazole
Omeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014