Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acid Peptic Disorder
Intervention: Buffered pantoprazole (Drug); Buffered pantoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Balagopal Nair, MD, Study Director, Affiliation: Abbott India Ltd.
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 patients suffering from acid peptic disorders.
Clinical Details
Official title: Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
Secondary outcome: Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed
endoscopically (reflux esophagitis, gastritis and peptic ulcer)
2. 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.
3. 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:
1. Total abstinence from sexual intercourse (minimum one completed menstrual cycle)
2. A vasectomized partner
3. Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
prior to study drug administration.
4. Intrauterine device (IUD)
5. Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring
with spermicidal jellies or creams)
Exclusion Criteria:
1. Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or
bleeding
2. Subjects who have a history of use of any antisecretory drug within past 7 days prior
study Day 0
3. Subjects with cardiac, neurological, renal or hepatic dysfunction
4. Past history of significant sensitivity or contraindication to study drug
5. Pregnant or breast-feeding female
6. Any condition that, in the opinion of the Investigator, does not justify the
subject's inclusion for the study
Locations and Contacts
Site Reference ID/Investigator# 42043, Chennai 600 096, India
Additional Information
For more information, click on the website link
Starting date: March 2011
Last updated: December 26, 2012
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