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

NCT00709046 | Unknown DMC

• 1 other identifier: 200710033M
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endoscopy; Peptic Ulcer; Bleeding; Proton Pump Inhibitors

Keywords

Endoscopic treatment; Peptic ulcer; Bleeding; Thermocoagulation; Proton pump inhibitors

Outcome Measures

Primary Outcomes (1)

• rate of initial hemostasis and the rate of recurrent bleeding

  72hr

Secondary Outcomes (1)

• need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality

  30day

Study Arms (2)

1

EXPERIMENTAL

High dose pantoprazole infusion

Drug: High dose pantoprazole infusion

2

ACTIVE COMPARATOR

standard dose pantoprazole infusion

Drug: Standard dose pantoprazole infusion

Interventions

High dose pantoprazole infusion DRUG

Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs

Also known as: Pantoloc

1

Standard dose pantoprazole infusion DRUG

Pantoprazole 40mg iv bolus qd x 3 days

Also known as: Pantoloc

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Chen CC, Lee JY, Fang YJ, Hsu SJ, Han ML, Tseng PH, Liou JM, Hu FC, Lin TL, Wu MS, Wang HP, Lin JT. Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers. Aliment Pharmacol Ther. 2012 Apr;35(8):894-903. doi: 10.1111/j.1365-2036.2012.05047.x. Epub 2012 Feb 28.

  PMID: 22369682 DERIVED

MeSH Terms

Conditions

Peptic Ulcer; Hemorrhage

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chieh-Chang Chen, MD

CONTACT

886-5-532-3911; chiehchang.chen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

TW (1)