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IV Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)

This study is currently recruiting participants.
Verified by Lotung Poh-Ai Hospital, July 2008

Sponsored by: Lotung Poh-Ai Hospital
Information provided by: Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier: NCT00731601
  Purpose

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 Intervention Phase
Peptic Ulcer Hemorrhage
Drug: pantoprazole
Phase IV

MedlinePlus related topics:   Peptic Ulcer   

Drug Information available for:   Pantoprazole    Pantoprazole Sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • The primary end point was recurrent bleeding before discharge and within 14 days. [ Time Frame: About one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 yr ] [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   May 2008
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
pantoprazole 40mg/q6h IV infusion for three days
Drug: pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
2: Active Comparator
pantoprazole 8mg/h for three days
Drug: pantoprazole
pantoprazole 8 mg/h IV infusion for three days

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731601

Contacts
Contact: Hwai-jeng Lin, M.D.     886-39543131 ext 5400     hjlin@mail.pohai.org.tw    
Contact: Yun-chen chien     886-39543131 ext 5411     909010@mail.pohai.org.tw    

Locations
Taiwan
Lotung Poh-Ai hospital     Recruiting
      Yilan, Taiwan, 26514
      Contact: Hwai-jeng Lin, m.d.     88639543131 ext 5400     hjlin@mail.pohai.org.tw    
      Principal Investigator: Hwai-jeng Lin, M.D.            

Sponsors and Collaborators
Lotung Poh-Ai Hospital

Investigators
Principal Investigator:     Hwai-jeng Lin, M.D.     Lotung Poh-Ai Hospital    
  More Information


Responsible Party:   Lotung Poh-Ai Hospital ( Lin, Hwai-jeng, M.D. FACG )
Study ID Numbers:   LotungPAH
First Received:   August 7, 2008
Last Updated:   August 8, 2008
ClinicalTrials.gov Identifier:   NCT00731601
Health Authority:   Taiwan: Department of Health

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

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Shock
Gastrointestinal Diseases
Pantoprazole
Ulcer
Peptic Ulcer Hemorrhage
Gastrointestinal Hemorrhage
Intestinal Diseases
Hemorrhage
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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