MedTrace Logo

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

NCT01123031 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DRUG

lansoprazole

lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months

DRUG

esomeprazole

esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months

Sponsors & Collaborators

  • Changhua Christian Hospital

    lead OTHER

Principal Investigators

  • Hwai J Lin, M.D. · Changhua Christian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-03-31
Completion
2012-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123031 on ClinicalTrials.gov