A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Taipei Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT01275937
First received: January 12, 2011
Last updated: August 11, 2011
Last verified: August 2011
  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. However, low dose of PPI has also been supported in the management of these patients.

The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.

In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 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: Esomeprazole
Drug: esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding

Resource links provided by NLM:


Further study details as provided by Taipei Medical University:

Primary Outcome Measures:
  • Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    recurrent bleeding before discharge and within 14 days


Secondary Outcome Measures:
  • Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Esomeprazole
Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.
Drug: Esomeprazole
Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
Other Name: Esomeprazole
Active Comparator: esomeprazole
esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months.
Drug: Esomeprazole
Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
Other Name: Esomeprazole
Drug: esomeprazole
esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily 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 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. However, low dose of PPI has also been supported in the management of these patients.

We enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.

In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a peptic with active bleeding, a non-bleeding visible vessel or an adherent blood clot at the ulcer base is observed within24 hours of hospital admission

Exclusion Criteria:

  • Patients are excluded from the study if they are pregnant, do not obtain initial hemostasis with endoscopic injection 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: NCT01275937

Contacts
Contact: Hwai-jeng Lin, Doctor 886-2-27372181 buddhistlearning@gmail.com

Locations
Taiwan
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Hwai-jeng Lin, M.D.    886-2-27372181 ext 3040    buddhistlearning@gmail.com   
Principal Investigator: Hwai-jeng Lin, M.D.         
Sponsors and Collaborators
Taipei Medical University
Investigators
Study Chair: Hwai-jeng Lin, MD Taipei Medical University
  More Information

No publications provided

Responsible Party: Lin Hwai-Jeng, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01275937     History of Changes
Other Study ID Numbers: TMUH-2011
Study First Received: January 12, 2011
Last Updated: August 11, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014