Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
Overview[ - collapse ][ - ]
| Purpose | 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 | Peptic Ulcer Hemorrhage |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier | NCT00040495 |
| First Received | June 26, 2002 |
| Last Updated | February 7, 2013 |
| Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 26, 2002 |
|---|---|
| Last Updated Date | February 7, 2013 |
| Start Date | April 2001 |
| Estimated Primary Completion Date | January 2003 |
| 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 | An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Prevention |
| Condition | Peptic Ulcer Hemorrhage |
| Intervention | Drug: Pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 149 |
| Estimated Completion Date | January 2003 |
| Estimated Primary Completion Date | January 2003 |
| Eligibility 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 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 | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00040495 |
|---|---|
| Other Study ID Numbers | 3001K2-315 |
| 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 |