Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
NCT00037570
ABOUT THIS STUDY
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- 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)
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage | |||
Official Title ICMJE | A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer | |||
Brief Summary | This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized 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 | 12 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2002 | |||
Actual Primary Completion Date | February 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00037570 | |||
Other Study ID Numbers ICMJE | 3001K2-201 | |||
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 |
| |||
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 |