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

Phase 4

Completed

• Conditions: Acid Peptic Disorder
• Interventions: Drug: Buffered pantoprazole

• Registration Number: NCT01214408
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-03
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Study Start: 2011-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GRP-A	Buffered pantoprazole	-
GRP-B	Buffered pantoprazole	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 42043; 🇮🇳 Chennai, India