Overview

Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)

Status:
Withdrawn
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
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. Laine and Javid et al found that oral PPI and IV PPI had a similar intragastric pH response in the past two years. Therefore, whether oral can replace IV in the management of peptic ulcer bleeding is the objective in this study. The investigators enrolled 130 patients with active bleeding or nonbleeding visible vessels（NBVV） in this study. They are randomly assigned as oral lansoprazole or IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement. In the lansoprazole group (N=65), 30 mg four times daily is given orally for three days. Thereafter, the patients receive 30 mg lansoprazole orally daily for two months. In the nexium group, 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Changhua Christian Hospital
Treatments:
Dexlansoprazole
Esomeprazole
Lansoprazole
Proton Pump Inhibitors
Criteria
Inclusion Criteria:

- A peptic ulcer with active bleeding,a non-bleeding visible vessel (NBVV) or an
adherent blood clot at the ulcer base is observed within 24 hours of hospital
admission

Exclusion Criteria:

- Patients are excluded from the study if they are pregnant,

- Do not obtain initial hemostasis with endoscopic injection of epinephrine

- Do not give written informed consent

- Have bleeding tendency (platelet count <50×109/L,serum prothrombin <30% of normal,or
were taking anticoagulants)

- Uremia.