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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014