Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.

Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.

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.

Study Overview

• Status: Completed
• Conditions: Acid Peptic Disorder
• Intervention / Treatment: Drug: Buffered pantoprazole

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600 096
    • Site Reference ID/Investigator# 42043

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRP-A	Drug: Buffered pantoprazole; Buffered pantoprazole 40 mg QD; Other Names: ABT-897, Buffered Pantoprazole, Digene Total
Experimental: GRP-B	Drug: Buffered pantoprazole; Buffered pantoprazole 40 mg QD; Other Names: ABT-897, Buffered Pantoprazole, Digene Total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)	Assessment done on day 1 for group A subjects

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)	Assessment done on day 7 for all subjects
24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)	Assessment done on day 1 for group A subjects

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Balagopal Nair, MD, Abbott

Publications and helpful links

Helpful Links

• For more information, click on the website link

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 3, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimate): October 5, 2010

Study Record Updates

• Last Update Posted (Estimate): December 28, 2012
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: R12-576