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Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)

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ClinicalTrials.gov Identifier: NCT00731601
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : April 7, 2009
Sponsor:
Information provided by:
Lotung Poh-Ai Hospital

Brief Summary:
A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: pantoprazole Phase 4

Detailed Description:

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .

The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
pantoprazole 40mg/q6h IV infusion for three days
Drug: pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
Other Name: pantoloc
Active Comparator: 2
pantoprazole 8mg/h for three days
Drug: pantoprazole
pantoprazole 8 mg/h IV infusion for three days
Other Name: pantoloc



Primary Outcome Measures :
  1. The primary end point was recurrent bleeding before discharge and within 14 days. [ Time Frame: About one year ]

Secondary Outcome Measures :
  1. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared. [ Time Frame: about one year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.

Exclusion Criteria:

  • If patients were pregnant
  • Did not obtain initial hemostasis with endoscopic injection of epinephrine
  • Did not give written informed consent
  • Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731601


Locations
Taiwan
Lotung Poh-Ai hospital
Yilan, Taiwan, 26514
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Investigators
Principal Investigator: Hwai-jeng Lin, M.D. Lotung Poh-Ai Hospital

Responsible Party: Lin, Hwai-jeng, M.D. FACG, Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier: NCT00731601     History of Changes
Other Study ID Numbers: LotungPAH
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by Lotung Poh-Ai Hospital:
shock
peptic ulcer bleeding
rebleeding

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Pantoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action