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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRP-A | Experimental |
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| GRP-B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buffered pantoprazole | Drug | Buffered pantoprazole 40 mg QD |
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| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Balagopal Nair, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 42043 | Chennai | 600 096 | India |
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| Label | URL |
|---|---|
| For more information, click on the website link | View source |
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| Buffered pantoprazole | Drug | Buffered pantoprazole 40 mg QD |
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