A Study to Monitor Intragastric pH in Patients Taking Rabeprazole vs. Patients Taking Pantoprazole
Information source: Janssen-Ortho Inc., Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD
Intervention: rabeprazole sodium (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen-Ortho Inc., Canada Official(s) and/or principal investigator(s): Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: 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)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
A Randomized, Controlled, Double-blind, Cross-over Study of the Effect of Oral Rabeprazole 20mg and Intravenous Pantoprazole 40mg on Intragastric pH in Patients
Starting date: October 2005
Last updated: December 7, 2012
|