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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site Reference ID/Investigator# 42043

Chennai, 600 096, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)
  • 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.
  • 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:
  • Total abstinence from sexual intercourse (minimum one completed menstrual cycle)
  • A vasectomized partner
  • Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration.
  • Intrauterine device (IUD)
  • Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams)

Exclusion criteria

  • Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
  • Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
  • Subjects with cardiac, neurological, renal or hepatic dysfunction
  • Past history of significant sensitivity or contraindication to study drug
  • Pregnant or breast-feeding female
  • Any condition that, in the opinion of the Investigator, does not justify the subject's inclusion for the study

Treatment and study plan

Buffered pantoprazole

Drug

Buffered pantoprazole 40 mg QD

Other names: ABT-897, Buffered Pantoprazole, Digene Total

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)

    Time frame: Assessment done on day 1 for group A subjects

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Dec 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.