Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lansoprazole
esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Upper Gastrointestinal Bleeding
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lansoprazole
esomeprazole
Arm Description
lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
Outcomes
Primary Outcome Measures
Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy
recurrent bleeding before discharge and within 14 days
Secondary Outcome Measures
hospital stay
we measure the above item in high risk patients during hospitalization and within one month
volume of blood transfusion
we measure the above item in high risk patients during hospitalization and within one month
numbers of operation
we measure the above item in high risk patients during hospitalization and within one month
numbers of death
we measure the above item in high risk patients during hospitalization and within one month
Full Information
NCT ID
NCT01123031
First Posted
April 13, 2010
Last Updated
February 13, 2020
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01123031
Brief Title
Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)
Official Title
Oral vs Intravenous Proton Pump Inhibitor(PPI) in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was terminated and the PI has left the institution.
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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 (1) and is now recommended as the first hemostatic modality for these patients (1, 2).
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis (3-8). To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. In our study, the investigators used 40 mg omeprazole intravenous bolus followed by 160 mg/day continuously infusion for three days. The mean intragastric pH rose to 6.0 one hour after the initial bolus of omeprazole in the omeprazole group; it persisted around this value for the rest of the 24 hours.7 The rebleeding rates were much lower in the PPI as compared with H2RA group (Day 3: 0/50 vs 8/50, p<0.01; Day 14: 2/50 vs 12/50, p<0.01) (4).
How about the route of PPI usage? Oral or IV is the preferred route? Laine et al used oral lansoprazole in patients with peptic ulcer bleeding.9 They were randomly assigned to intravenous lansoprazole (90-mg bolus followed by 9-mg/h infusion) or oral lansoprazole (120-mg bolus followed by 30 mg every 3 hours). A pH was recorded for 24 hours. Mean pH rose above 6 after 2-3 hours of intravenous PPI and 3-4 hours of oral PPI. They concluded that frequent oral PPI may be able to replace the currently recommended intravenous bolus plus infusion PPI therapy in patients with bleeding ulcers. In one recent article, Javid et al also proved that there was no significant difference among various PPIs (omeprazole, pantoprazole, and rabeprazole) given through different routes (IV and oral routes) on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer.10 In our recent study, the investigators have proved that oral rabeprazole and IV omeprazole are equally effective in preventing rebleeding (13/78 in rabeprazole vs 12/78 in omeprazole, p>0.1) in high-risk bleeding peptic ulcers.11 All secondary outcomes between the two groups were similar, including the amount of blood transfusion, hospital stay, need for surgery and mortality.
The objectives of this study are to assess the outcomes of two different regimens of oral lansoprazole vs high dose of intravenous nexium after endoscopic therapy in patients with peptic ulcer bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lansoprazole
Arm Type
Active Comparator
Arm Description
lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
Arm Title
esomeprazole
Arm Type
Active Comparator
Arm Description
esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
Intervention Type
Drug
Intervention Name(s)
lansoprazole
Other Intervention Name(s)
takeprone
Intervention Description
lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
nexium
Intervention Description
esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
Primary Outcome Measure Information:
Title
Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy
Description
recurrent bleeding before discharge and within 14 days
Time Frame
one year
Secondary Outcome Measure Information:
Title
hospital stay
Description
we measure the above item in high risk patients during hospitalization and within one month
Time Frame
one year
Title
volume of blood transfusion
Description
we measure the above item in high risk patients during hospitalization and within one month
Time Frame
one year
Title
numbers of operation
Description
we measure the above item in high risk patients during hospitalization and within one month
Time Frame
one year
Title
numbers of death
Description
we measure the above item in high risk patients during hospitalization and within one month
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwai J Lin, M.D.
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
22681960
Citation
Yen HH, Yang CW, Su WW, Soon MS, Wu SS, Lin HJ. Oral versus intravenous proton pump inhibitors in preventing re-bleeding for patients with peptic ulcer bleeding after successful endoscopic therapy. BMC Gastroenterol. 2012 Jun 8;12:66. doi: 10.1186/1471-230X-12-66.
Results Reference
derived
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Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)
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