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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01214408
First received: October 3, 2010
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Acid Peptic Disorder
Drug: Buffered pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole) [ Time Frame: Assessment done on day 1 for group A subjects ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole) [ Time Frame: Assessment done on day 7 for all subjects ] [ Designated as safety issue: No ]
  • 24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole) [ Time Frame: Assessment done on day 1 for group A subjects ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRP-A Drug: Buffered pantoprazole
Buffered pantoprazole 40 mg QD
Other Name: ABT-897, Buffered Pantoprazole, Digene Total
Experimental: GRP-B Drug: Buffered pantoprazole
Buffered pantoprazole 40 mg QD
Other Name: ABT-897, Buffered Pantoprazole, Digene Total

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214408

Locations
India
Site Reference ID/Investigator# 42043
Chennai, India, 600 096
Sponsors and Collaborators
Abbott
Investigators
Study Director: Balagopal Nair, MD Abbott India Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01214408     History of Changes
Other Study ID Numbers: R12-576
Study First Received: October 3, 2010
Last Updated: December 26, 2012
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Disease
Pathologic Processes
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014