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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.

NCT ID: NCT01214408

Last Updated: 2012-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-07-31

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.

Detailed Description

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Conditions

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Acid Peptic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GRP-A

Group Type EXPERIMENTAL

Buffered pantoprazole

Intervention Type DRUG

Buffered pantoprazole 40 mg QD

GRP-B

Group Type EXPERIMENTAL

Buffered pantoprazole

Intervention Type DRUG

Buffered pantoprazole 40 mg QD

Interventions

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Buffered pantoprazole

Buffered pantoprazole 40 mg QD

Intervention Type DRUG

Buffered pantoprazole

Buffered pantoprazole 40 mg QD

Intervention Type DRUG

Other Intervention Names

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ABT-897, Buffered Pantoprazole, Digene Total ABT-897, Buffered Pantoprazole, Digene Total

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Balagopal Nair, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 42043

Chennai, , India

Site Status

Countries

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India

Related Links

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http://dailymed.nlm.nih.gov/dailymed/about.cfm

For more information, click on the website link

Other Identifiers

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R12-576

Identifier Type: -

Identifier Source: org_study_id