Status:
COMPLETED
Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.
Lead Sponsor:
Abbott
Conditions:
Acid Peptic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This prospective, open label, single-center and non-comparative study is designed to generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition effect in patie...
Eligibility Criteria
Inclusion
- Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)
- Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures.
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- Total abstinence from sexual intercourse (minimum one completed menstrual cycle)
- A vasectomized partner
- Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration.
- Intrauterine device (IUD)
- Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams)
Exclusion
- Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
- Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
- Subjects with cardiac, neurological, renal or hepatic dysfunction
- Past history of significant sensitivity or contraindication to study drug
- Pregnant or breast-feeding female
- Any condition that, in the opinion of the Investigator, does not justify the subject's inclusion for the study
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01214408
Start Date
March 1 2011
End Date
July 1 2011
Last Update
December 28 2012
Active Locations (1)
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1
Site Reference ID/Investigator# 42043
Chennai, India, 600 096