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NCT Number: NCT01153659

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 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E3810

Drug

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

Aciphex (rabeprazole)

Drug

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

Nexium (esomeprazole)

Drug

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

Primary outcomes

  1. Percentage of time that intragastric pH remains >4

    Time frame: 24-hr period post-dose on Day 5

Secondary outcomes

  1. Percentage of day- and night-time periods with intragastric pH >4

    Time frame: Days 1 and 5

  2. Number and duration of nocturnal acid breakthrough (NAB) episodes

    Time frame: Days 1 and 5

  3. Proportion of subjects with nocturnal acid breakthrough (NAB) episodes

    Time frame: Days 1 and 5

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2010
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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