Clinical trial NCT01214408: Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.
Official title: Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acid Peptic Disorder
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
timeFrame: Assessment done on day 1 for group A subjects
Secondary outcomes:
measure: Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)
timeFrame: Assessment done on day 7 for all subjects
measure: 24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)
timeFrame: Assessment done on day 1 for group A subjects
Other outcomes:
Locations:
city: Chennai
country: India
facility: Site Reference ID/Investigator# 42043
Study officials:
affiliation: Abbott
name: Balagopal Nair, MD
role: STUDY_DIRECTOR
References: