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

NCT01123031 | Withdrawn Phase 4

• 1 other identifier: CCH-100118
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy

  recurrent bleeding before discharge and within 14 days

  one year

Secondary Outcomes (4)

• hospital stay

  one year

• volume of blood transfusion

  one year

• numbers of operation

  one year

• numbers of death

  one year

Study Arms (2)

lansoprazole

ACTIVE COMPARATOR

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

Drug: lansoprazole

esomeprazole

ACTIVE COMPARATOR

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

Drug: esomeprazole

Interventions

lansoprazole DRUG

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

Also known as: takeprone

lansoprazole

esomeprazole DRUG

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

Also known as: nexium

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Related Publications (1)

• 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.

  PMID: 22681960 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Lansoprazole; Esomeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hwai J Lin, M.D.

  Changhua Christian Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: May 14, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 17, 2020

Record last verified: 2020-02