Peptic Ulcer Hemorrhage Clinical Trial
Official title:
Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 2 Trail in China
The purpose of this study is to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, ilaprazole and omeprazole, to be treated for up to 30 days and be seen at day 3, 4, 7, 14 and 30. The primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end points include effective rate of hemostasis, mean volume of blood transfusion, the length of stay and re-bleeding rate, etc.
Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 120 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to oral administration. Other 60 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min. Since 4th day, those patients were changed to oral administration. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpoint including the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate (bleeding groups with endoscopy check) within 72 hours and secondary end points including effective rate of hemostasis, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), hospital stay and re-bleeding rate at day 7, 14 and 30. Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes,including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.This phase Ⅱ clinical trial was designed to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01125852 -
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
|
N/A | |
Completed |
NCT00840008 -
The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding
|
Phase 4 | |
Terminated |
NCT00164905 -
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
|
N/A | |
Completed |
NCT05563714 -
Anticoagulation With Enhanced Gastrointestinal Safety
|
N/A | |
Completed |
NCT03362281 -
Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
|
Phase 3 | |
Completed |
NCT00164931 -
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
|
Phase 3 | |
Completed |
NCT04211194 -
Registry for Upper Gastrointestinal Bleeding
|
||
Completed |
NCT01241266 -
China Survey of Peptic Ulcer Bleeding
|
N/A | |
Completed |
NCT00037570 -
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
|
Phase 2 | |
Completed |
NCT00731601 -
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
|
Phase 4 | |
Completed |
NCT05248321 -
Precise Delivery of Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding
|
N/A | |
Recruiting |
NCT00687336 -
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
|
Phase 4 | |
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 |
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 | |
Completed |
NCT02197039 -
The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
|