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

NCT01153659 | Completed Phase 1

• 1 other identifier: E3810-A001-038
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

rabeprazole; esomeprazole; h. pylori-negative; nocturnal acid breakthrough; intragastric pH, PK/PD; effect on gastric pH in healthy, H. pylori-Negative subjects

Outcome Measures

Primary Outcomes (1)

• Percentage of time that intragastric pH remains >4

  24-hr period post-dose on Day 5

Secondary Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

Drug: E3810

2

ACTIVE COMPARATOR

Drug: Aciphex (rabeprazole)

3

ACTIVE COMPARATOR

Drug: Nexium (esomeprazole)

Interventions

E3810 DRUG

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

1

Aciphex (rabeprazole) DRUG

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

2

Nexium (esomeprazole) DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Rabeprazole; Esomeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole

Study Officials

• Philip Miner

  Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)