A Study to Monitor Intragastric pH in Patients Taking Rabeprazole vs. Patients Taking Pantoprazole

NCT00378287 | Completed Phase 1

• 1 other identifier: CR005824
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to demonstrate in patients that oral rabeprazole produces equivalent acid suppression to intravenous pantoprazole on Day 1 of drug administration.

Conditions

GERD

Keywords

Acid Reflux; Proton Pump Inhibitor; GERD

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is the percentage of time intragastric pH >4 for the 24-hour monitoring period on Day 1 (i.e.: first day of dosing for each treatment period).

Secondary Outcomes (1)

• Percentage of time intragastric pH is >3, >4, >5, >6 on Day 1, and on Day 3 over time intervals: 0-14h and 14-24h after dosing;Median intragastric pH on Day 1 and Day 3 (entire 24-hour interval, and over time intervals: 0-14h and 14-24h after dosing)

Interventions

rabeprazole sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients must be postmenopausal (for at least 1 year), sterile (6 months post-sterilization), or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Patients of childbearing potential (including those using birth control) must have a negative pregnancy serum test at screening before medication is dispensed
• Absence of Hp infection, as established by a negative 13C-urea breath test (13C-UBT)
• Body mass index (BMI) between 18-33 kg/m2, and weight between 50 and 135kg. BMI calculation: BMI = weight (kg) / height (m) 2

You may not qualify if:

• Documentation of significant past history of gastrointestinal disease requiring therapy
• Patients with a baseline pH recording indicative of an abnormal acid secretory pattern
• Significant concurrent disease or clinical illness within 14 days of initial screening visit
• Use of any prescription medications within 14 days of initial screening visit, with the exception of oral contraceptive medications, and non-systemic medications such as topical medications for skin conditions, or nasal sprays for allergy relief
• Use of either over-the-counter (OTC) or prescription histamine-2 receptor antagonists (H2RAs), and/or proton pump inhibitors (PPIs) prokinetics, antibiotics or bismuth compounds within 28 days of the screening 13C-UBT
• Use of any OTC medication within 7 days of the initial screening visit, with the exception of acetaminophen (up to a daily maximum of 2g), and OTC eye drops, nasal drops or sprays for allergy relief.10.

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Publications (1)

• Armstrong D, James C, Camacho F, Chen Y, Horbay GL, Teixeira B, Husein-Bhabha FA. Oral rabeprazole vs. intravenous pantoprazole: a comparison of the effect on intragastric pH in healthy subjects. Aliment Pharmacol Ther. 2007 Jan 15;25(2):185-96. doi: 10.1111/j.1365-2036.2006.03160.x. Epub 2006 Nov 16.

  PMID: 17116123 RESULT

Related Links

• A Randomized, Controlled, Double-blind, Cross-over Study of the Effect of Oral Rabeprazole 20mg and Intravenous Pantoprazole 40mg on Intragastric pH in Patients

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 19, 2006
• Study Start: October 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 10, 2012

Record last verified: 2012-12