Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00037570 |
Recruitment Status :
Completed
First Posted : May 20, 2002
Last Update Posted : February 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peptic Ulcer Hemorrhage | Drug: Pantoprazole | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Primary Purpose: | Prevention |
Official Title: | A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer |
Study Start Date : | November 2000 |
Actual Primary Completion Date : | February 2002 |
Actual Study Completion Date : | February 2002 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be men or nonpregnant women at least 18 years of age
- Patients who present with a gastric or duodenal ulcer (major dimension of the ulcer must be ≥ 5 mm and ≤ 20 mm) with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV) Patients presenting with adherent protruding clot are eligible if, after removal of the clot by irrigation, the underlying lesion is classified as spurting, oozing or a NBVV. Patients with an actively bleeding ulcer or a NBVV within a hiatal hernia are eligible if the ulcer is located below the Z-line)
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037570
United States, California | |
Los Angeles, California, United States, 90073 | |
San Diego, California, United States, 62103-8401 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45267-0595 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Texas | |
Houston, Texas, United States, 77030-4211 | |
United States, Virginia | |
Norfolk, Virginia, United States, 23507 |
Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00037570 |
Other Study ID Numbers: |
3001K2-201 |
First Posted: | May 20, 2002 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | February 2013 |
Peptic Ulcer Hemorrhage |
Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Hemorrhage Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Stomach Diseases Gastrointestinal Hemorrhage Pantoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |