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

NCT01275937 | Unknown Phase 4

• 1 other identifier: TMUH-2011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.

  recurrent bleeding before discharge and within 14 days

  two years

Secondary Outcomes (1)

• Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.

  two years

Study Arms (2)

Esomeprazole

OTHER

Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.

Drug: Esomeprazole

esomeprazole

ACTIVE COMPARATOR

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

Drug: Esomeprazole

Interventions

esomeprazole DRUG

Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.

Esomeprazole; esomeprazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hwai-jeng Lin, MD

  Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Hwai-jeng Lin, Doctor

CONTACT

886-2-27372181; buddhistlearning@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

TW (1)