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Peptic Ulcer Hemorrhage Study - Article


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Pantoprazole

Protonix 




Clinical Trial: Peptic Ulcer Hemorrhage Study

This study is currently recruiting patients.

Sponsored by: Wyeth
Information provided by: Wyeth

Purpose

This study will evaluate the effect of two regimens of intravenous pantoprazole versus intravenous ranitidine on intragastric pH after endoscopic hemostatic therapy in patients with bleeding peptic ulcer.

Condition Treatment or Intervention Phase
Peptic Ulcer Hemorrhage
 Drug: Pantoprazole
Phase II

MedlinePlus related topics:  Gastrointestinal Bleeding

Study Type: Interventional
Study Design: Prevention, Randomized

Official Title: A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients with Bleeding Peptic Ulcer

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patients must be men or nonpregnant women at least 18 years of age.
  • Patients who present with a gastric or duodenal ulcer with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV).
  • Patients must be at high risk for rebleeding.
  • Successful endoscopic hemostasis must be established.
  • Patients must be capable of understanding and giving signed and dated informed consent.

Exclusion Criteria:

  • Patients with ulcer appearance of clean base 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 or severe injuries.
  • Patients with gastrointestinal bleeding other than peptic ulcer.
  • Patients who have undergone gastric acid reducing surgery (eg, vagotomy or antrectomy).

Location and Contact Information


California
      UCSD Medical Center, San Diego,  California,  62103-8401,  United States; No longer recruiting

      CURE/ West LA VA Medical Center, Los Angeles,  California,  90073,  United States; No longer recruiting

Ohio
      University of Cincinnati Hospital - College of Medicine, Cincinnati,  Ohio,  45267-0595,  United States; No longer recruiting

Pennsylvania
      Temple University Hospital - Gastroenterology, Philadelphia,  Pennsylvania,  19140,  United States; No longer recruiting

Texas
      Baylor College of Medicine VAMC, Houston,  Texas,  77030-4211,  United States; No longer recruiting

Virginia
      Sentara Norfolk General Hospital, Norfolk,  Virginia,  23507,  United States; Recruiting
David Johnson, MD  757-466-0165 

More Information

Study ID Numbers:  3001K2-201-US
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  May 17, 2002
ClinicalTrials.gov Identifier:  NCT00037570
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 28, 2009



Page Updated: September 6, 2005
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