Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

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 year ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
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

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

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

More Information

No publications provided

Responsible Party:	Lin, Hwai-jeng, M.D. FACG, Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:	NCT00731601 History of Changes
Other Study ID Numbers:	LotungPAH
Study First Received:	August 7, 2008
Last Updated:	April 6, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by Lotung Poh-Ai Hospital:

shock
peptic ulcer bleeding
rebleeding

Additional relevant MeSH terms:

Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

Gastrointestinal Hemorrhage
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012