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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

Page last updated: August 23, 2015

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