Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

NCT01182597 | Unknown Phase 3

• 1 other identifier: 201003039M
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar acid control as currently recommended intravenous infusion PPI did in patients with bleeding ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis.

Conditions

Peptic Ulcers

Keywords

Oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis

Outcome Measures

Primary Outcomes (1)

• Clinical rebleeding

  Clinical rebleeding defines: 1. Hematemesis, fresh blood in the NG tube aspirate 2. Hematochezia/melena after a normal stool 3. Decrease in Hb \>= 2 g/dL or an increase in Hb \< 1 g/dL during 24 hrs, despite \>=2 units of blood transfused during 24 hours 4. SBP \<= 90 mm Hg or HR \>= 110 beats/min AND melena/hematemesis

  30 days

Secondary Outcomes (4)

• Blood transfusion

  30 day

• Need of surgery

  30 days

• Lengths of hospital stay

  30 days

• Mortality rate

  30 days

Study Arms (2)

IV PPI

ACTIVE COMPARATOR

Pantoprazole 3.3mg/hr for 72hrs

Drug: Pantoprazole (Pantoloc)

Oral PPI

EXPERIMENTAL

Lansoprazole (Takepron OD) 30mg PO q12h

Drug: Lansoprazole (Takepron OD)

Interventions

Pantoprazole (Pantoloc) DRUG

Pantoprazole (Pantoloc) 3.3mg/hr for 72hrs

IV PPI

Lansoprazole (Takepron OD) DRUG

Lansoprazole (Takepron OD) 30mg q12h PO

Oral PPI

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Confirmed ulcer bleeding with Forrest Ia, Ib, IIa
• Endoscopic hemostasis achieved by combined endoscopic hemostasis
• Informed consent obtained

You may not qualify if:

• No consent
• Unsuccessful endoscopic treatment
• Upper GI malignancy
• History of subtotal gastrectomy
• Bleeding tendency, platelet count \< 80x109/L, prothrombin time INR \>1.5
• Myocardial infarction or cerebrovascular accident within one week
• Ulcer bleeding because of mechanical factors (such as, induction of NG tube)
• Malignancy or other advanced disease with a life expectancy of \< 6 months
• IV PPI \> 40mg within 24hrs before enrollment
• Decompensated liver cirrhosis
• Requiring dialysis
• Pregnant or lactating women
• History of allergy or severe side effects to lansoparzole or pantoprazole

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan Univeristy Hospital Yunlin Branch

Douliu, Taiwan, Taiwan

RECRUITING

National Taiwan Univeristy Hospital

Taipei, Taiwan, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Pantoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chieh-Chang Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-Chang Chen, MD

CONTACT

88655323911; chiehchang.chen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

TW (2)