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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acid Peptic Disorder

Intervention / Treatment
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* Drug: Buffered pantoprazole
* Drug: Buffered pantoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRP-A<br> | Drug: Buffered pantoprazole<br>* Buffered pantoprazole 40 mg QD<br>* Other names: ABT-897, Buffered Pantoprazole, Digene Total;|
| Experimental: GRP-B<br> | Drug: Buffered pantoprazole<br>* Buffered pantoprazole 40 mg QD<br>* Other names: ABT-897, Buffered Pantoprazole, Digene Total;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |