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

This study has been completed.
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00378287
First received: September 15, 2006
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
GERD
Drug: rabeprazole sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind, Cross-over Study of the Effect of Oral Rabeprazole 20mg and Intravenous Pantoprazole 40mg on Intragastric pH in Patients

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Enrollment: 37
Study Start Date: October 2005
Study Completion Date: December 2005
Detailed Description:

Following screening to determine eligibility (normal medical history, physical examination including vital signs, laboratory findings, negative test for active H. pylori infection, and a negative pregnancy test if applicable) and subsequent enrolment, patients will have a baseline 24-hour intragastric pH recording. Patients will receive either oral rabeprazole 20mg or intravenous pantoprazole 40mg daily for 3 consecutive days. For blinding purposes, patients will also receive either a placebo oral tablet or placebo intravenous solution ("double-dummy" design). A 24-hour intragastric pH recording will be completed on Day 1 and Day 3 of the drug administration period. This will be followed by a 14-day washout period before the second 3-day drug administration period during which the patient will receive the crossover drug regimen, and will again have 24-hour intragastric pH recordings completed on the first and third days of this second drug administration period.Thirty-seven patients with a negative test for active H. pylori infection test will be randomised into the study. The primary hypothesis is that oral rabeprazole produces equivalent acid suppression to intravenous pantoprazole as indicated by the time during which intragastric pH is greater than 4 on Day 1 of drug administration. Eligible patients will be randomly assigned to 1 of the 2 treatment groups and will first receive either oral rabeprazole 20mg plus placebo intravenous solution or intravenous pantoprazole 40mg plus a placebo oral tablet daily for 3 consecutive days. After a 14-day washout, patients will receive the crossover drug regimen.

Rabeprazole: supplied as 20mg tablets (and matching placebo tablets). Pantoprazole: supplied as 12-mL vials of lyophilized powder containing pantoprazole 40mg (pantoprazole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378287

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00378287     History of Changes
Other Study ID Numbers: CR005824
Study First Received: September 15, 2006
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:
Acid Reflux
Proton Pump Inhibitor
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Proton Pump Inhibitors
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014