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NCT00279123 Clinical Trial

Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

Peptic Ulcer Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00279123
Other study ID # PPI Trial
Secondary ID
Status Completed
Phase Phase 4
First received January 17, 2006
Last updated January 17, 2006
Start date January 2002

Study information
Verified date January 2006
Source Kwong Wah Hospital
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Hospital Authority
Study type Interventional

Clinical Trial Summary

Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion Criteria:

- previous gastrectomy and vagotomy

- patient taking warfarin

- intake of anti-secretory drugs in the previous 48 hours

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pantoprazole infusion

• pantoprazole bolus

• no treatment

Locations
Country Name City State
China Department of Surgery, Kwong Wah Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Kwong Wah Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rebleeding rate within 30 days after endoscopic therapy
Secondary Transfusion requirement
Secondary duration of hospital stay
Secondary need for operative intervention
Secondary mortality rate
Secondary gastric pH
Secondary side effects of pantoprazole
See also
  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 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
Completed NCT02197039 - The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers