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.

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

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

Criteria

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 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).

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; No longer recruiting
      USA Medical Center, Mobile,  Alabama,  36617,  United States; No longer recruiting
Arizona
      Carl T. Hayden VA Medical Center, Phoenix,  Arizona,  85012,  United States; No longer recruiting
California
      Sharp Memorial Hospital, San Diego,  California,  92123,  United States; Not yet recruiting
      San Francisco General Hospital, San Francisco,  California,  94110,  United States; No longer recruiting
      VAGLAHS, Los Angeles,  California,  90073,  United States; No longer recruiting
      University of California at San Diego, San Diego,  California,  92103,  United States; Recruiting
Colorado
      St. Anthony's Central Hospital, Denver,  Colorado,  80204,  United States; No longer recruiting
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States; No longer recruiting
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  20010,  United States; No longer recruiting
Georgia
      Emory University Hospital, Atlanta,  Georgia,  30322,  United States; No longer recruiting
Illinois
      Rush-Presbyterian St. Lukes Medical Center, Chicago,  Illinois,  60612,  United States; No longer recruiting
      Good Samaritan Hospital, Downers Grove,  Illinois,  60515,  United States; No longer recruiting
Iowa
      University of Iowa Hospital & Clinics, Iowa City,  Iowa,  52242,  United States; No longer recruiting
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118-2395,  United States; No longer recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; No longer recruiting
Missouri
      Barnes-Jewish Hospital, St. Louis,  Missouri,  63110-1093,  United States; No longer recruiting
      VA Medical Center Kansas City, Kansas City,  Missouri,  64218,  United States; No longer recruiting
New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States; No longer recruiting
New York
      VA Medical Center Northport, Northport,  New York,  11768,  United States; No longer recruiting
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States; No longer recruiting
      Wilson Memorial Regional Medical Center, Johnson City,  New York,  13790,  United States; No longer recruiting
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States; No longer recruiting
North Carolina
      University of North Carolina Memorial Hospital, Chapel Hill,  North Carolina,  27514,  United States; No longer recruiting
Pennsylvania
      MCP Hahnemann University, Philadelphia,  Pennsylvania,  19129,  United States; No longer recruiting
      Thomas Jefferson University, Philadelphia,  Pennsylvania,  19104,  United States; No longer recruiting
Virginia
      VA Medical Center, Richmond,  Virginia,  23249,  United States; No longer recruiting
      Sentara Virginia Beach General Hospital, Virginia Beach,  Virginia,  23454,  United States; No longer recruiting
      Sentara Norfolk General Hospital, Norfolk,  Virginia,  23507,  United States; No longer recruiting
      St. Mary's Hospital, Richmond,  Virginia,  23226,  United States; No longer recruiting
Washington
      Overlake Hospital Medical Center, Bellevue,  Washington,  98004,  United States; No longer recruiting
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; No longer recruiting
Wisconsin
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53201-2901,  United States; No longer recruiting

Study ID Numbers:  3001K2-315-US
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  June 26, 2002
ClinicalTrials.gov Identifier:  NCT00040495
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08