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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01214408

Enrollment

Registered

2010-10-05

Start date

2011-03-31

Completion date

2011-07-31

Last updated

2012-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid Peptic Disorder

Brief summary

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.

Interventions

DRUGBuffered pantoprazole

Buffered pantoprazole 40 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026