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NCT00040495 Clinical Trial

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Peptic Ulcer Hemorrhage Clinical Trial

Official title:
An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00040495
Other study ID # 3001K2-315
Secondary ID
Status Completed
Phase Phase 3
First received June 26, 2002
Last updated February 7, 2013
Start date April 2001
Est. completion date January 2003

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date January 2003
Est. primary completion date January 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Pantoprazole

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
See also
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Completed NCT00164931 - A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer Phase 3
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Completed NCT00037570 - Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage Phase 2
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Completed NCT05248321 - Precise Delivery of Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding N/A
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Not yet recruiting NCT06273384 - Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
Terminated NCT00165009 - Resolution Endoclips Vs Epinephrine Injection and Heater Probe Phase 3
Completed NCT03163680 - Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
Completed NCT00279123 - Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers Phase 4
Completed NCT03362268 - IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients Phase 2
Completed NCT00573924 - Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers N/A
Withdrawn NCT02724150 - Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding Phase 4
Active, not recruiting NCT04536428 - ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding N/A