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

Abbott

Status and phase: Completed; Phase 4

Conditions: Acid Peptic Disorder

Treatments: Drug: Buffered pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214408

R12-576

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

GRP-A

Experimental group

Treatment:

Drug: Buffered pantoprazole

Drug: Buffered pantoprazole

GRP-B

Experimental group

Treatment:

Drug: Buffered pantoprazole

Drug: Buffered pantoprazole