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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Changhua Christian Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01123031
First received: April 13, 2010
Last updated: January 18, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Upper Gastrointestinal Bleeding
Drug: lansoprazole
Drug: esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Oral vs Intravenous Proton Pump Inhibitor(PPI) in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial

Resource links provided by NLM:


Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    recurrent bleeding before discharge and within 14 days


Secondary Outcome Measures:
  • hospital stay [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    we measure the above item in high risk patients during hospitalization and within one month

  • volume of blood transfusion [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    we measure the above item in high risk patients during hospitalization and within one month

  • numbers of operation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    we measure the above item in high risk patients during hospitalization and within one month

  • numbers of death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    we measure the above item in high risk patients during hospitalization and within one month


Estimated Enrollment: 65
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lansoprazole
lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
Drug: lansoprazole
lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
Other Name: takeprone
Active Comparator: esomeprazole
esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
Drug: esomeprazole
esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
Other Name: nexium

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123031

Sponsors and Collaborators
Changhua Christian Hospital
Investigators
Study Chair: Hwai J Lin, M.D. Changhua Christian Hospital
  More Information

No publications provided by Changhua Christian Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lin Hwai-Jeng, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01123031     History of Changes
Other Study ID Numbers: CCH-100118
Study First Received: April 13, 2010
Last Updated: January 18, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Lansoprazole
Omeprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014