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Trial record 1 of 1 for:    NCT00040495
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Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

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ClinicalTrials.gov Identifier: NCT00040495
Recruitment Status : Completed
First Posted : June 28, 2002
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE June 26, 2002
First Posted Date  ICMJE June 28, 2002
Last Update Posted Date February 8, 2013
Study Start Date  ICMJE April 2001
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00040495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Official Title  ICMJE An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis
Brief Summary The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE Peptic Ulcer Hemorrhage
Intervention  ICMJE Drug: Pantoprazole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February¬†7,¬†2013)
149
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2003
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be men or non-pregnant women at least 18 years of age
  • Patients who present with a gastric or duodenal ulcer

Exclusion Criteria:

  • Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
  • Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
  • Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00040495
Other Study ID Numbers  ICMJE 3001K2-315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP