Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Peptic Ulcer Hemorrhage |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 2 |
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier | NCT00037570 |
| First Received | May 17, 2002 |
| Last Updated | February 7, 2013 |
| Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 17, 2002 |
|---|---|
| Last Updated Date | February 7, 2013 |
| Start Date | November 2000 |
| Estimated Primary Completion Date | February 2002 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage |
|---|---|
| Official Title | 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 | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Primary Purpose: Prevention |
| Condition | Peptic Ulcer Hemorrhage |
| Intervention | Drug: Pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 12 |
| Estimated Completion Date | February 2002 |
| Estimated Primary Completion Date | February 2002 |
| Eligibility 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 (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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00037570 |
|---|---|
| Other Study ID Numbers | 3001K2-201 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer |
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer |
| Verification Date | February 2013 |
Locations[ + expand ][ + ]
| United States, California | Los Angeles, California, United States, 90073 |
|---|---|
| United States, California | 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 |