Status:
COMPLETED
A Study to Monitor Intragastric pH in Patients Taking Rabeprazole vs. Patients Taking Pantoprazole
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
GERD
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 preg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00378287
Start Date
October 1 2005
End Date
December 1 2005
Last Update
December 10 2012
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