Trial record 5 of 57 for:    Open Studies | "Peptic Ulcer"

High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00709046
First received: June 30, 2008
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.


Condition Intervention
Endoscopy
Peptic Ulcer
Bleeding
Proton Pump Inhibitors
Drug: High dose pantoprazole infusion
Drug: Standard dose pantoprazole infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • rate of initial hemostasis and the rate of recurrent bleeding [ Time Frame: 72hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality [ Time Frame: 30day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High dose pantoprazole infusion
Drug: High dose pantoprazole infusion
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
Other Name: Pantoloc
Active Comparator: 2
standard dose pantoprazole infusion
Drug: Standard dose pantoprazole infusion
Pantoprazole 40mg iv bolus qd x 3 days
Other Name: Pantoloc

Detailed Description:

Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding
  • read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)
  • peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)

Exclusion Criteria:

  • unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)
  • bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin)
  • gastric malignancy
  • myocardial infarction within recent one week
  • recent cerebrovascular event within recent one week
  • pregnancy
  • refuse to attend the study
  • known allergy history to epinephrine or pantoprazole
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709046

Contacts
Contact: Chieh-Chang Chen, MD 886-5-532-3911 ext 2200 chiehchang.chen@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chieh-Chang Chen, MD    886-5-532-3911 ext 2200    chiehchang.chen@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chieh-Chang Chen, National Taiwan Univeritsy Hospital
ClinicalTrials.gov Identifier: NCT00709046     History of Changes
Other Study ID Numbers: 200710033M
Study First Received: June 30, 2008
Last Updated: January 11, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Endoscopic treatment
Peptic ulcer
Bleeding
Thermocoagulation
Proton pump inhibitors

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
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 April 20, 2014