Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy

NCT01142245 | Completed Phase 3

• 1 other identifier: IOE
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population. The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.

Conditions

Peptic Ulcer; Bleeding

Keywords

ulcer bleeding; endoscopic therapy

Outcome Measures

Primary Outcomes (1)

• Rate of clinical rebleeding within 30 day of endoscopic therapy

  Definition of clinical rebleeding 1. Recurrent hematemesis 2. fresh melena after normal stool 3. Hypotension SBP\<90 or tachycardia \>110 AND fresh melena 4. Decrease in Hb \>2g/dL (or Hct \> 10%) during any 24 h or an increas in Hb \<1 g/dL (or Hct \<3%) despite ≥4 units of blood has been transfused during any 48h

  30 days

Secondary Outcomes (7)

• Un-scheduled further endoscopic therapy

  30 days

• Need for surgery

  30 days

• Duration of hospitalization

  30 days

• Blood transfusion

  30 days

• mortality

  30 days

Study Arms (2)

oral esomeprazole

ACTIVE COMPARATOR

* Esomeprazole placebo IV loading bolus * Esomeprazole placebo intravenous infusion for 72 hours * Oral Esomeprazole: 80 mg/Day on Day 1, 2 and Day 3, and the drug will be given as 40 mg q12h.

Drug: Oral esomeprazole

Intravenous Esomeprazole

ACTIVE COMPARATOR

Esomeprazole IV loading bolus 80mg • Esomeprazole intravenous infusion 8mg/hr for 72 hours

Drug: Intravenous Esomeprazole

Interventions

Oral esomeprazole DRUG

• Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h

Also known as: oral, nexium

oral esomeprazole

Intravenous Esomeprazole DRUG

Esomeprazole IV 80mg loading bolus * Esomeprazole intravenous infusion 8mg/hr for 72 hours

Also known as: IV, nexium

Intravenous Esomeprazole

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb
• Endoscopic hemostasis achieved
• Informed consent obtained

You may not qualify if:

• No consent
• Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding)
• Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated
• Moribund patients in whom active treatment of any form is not considered.
• Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation
• Upper GI malignancy or disseminated malignant disease
• Esophageal varices
• A Mallory-Weiss lesion
• Phenytoin or theophylline treatment

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Endoscopy Centre

Hong Kong, 852, China

Location

Endoscopy Center in Prince of Wales Hospital

Hong Kong (sar), China

Location

MeSH Terms

Conditions

Peptic Ulcer; Hemorrhage

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; 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

• Francis K Chan, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

CN (2)