A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole

NCT00164788 | Terminated Phase 2

• 1 other identifier: Ne_pH
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.

Conditions

Gastrointestinal Hemorrhage

Keywords

24 hours pH monitoring

Outcome Measures

Primary Outcomes (1)

• The primary measure of this study is the median gastric pH over 24-hour monitoring.

  24 hours

Secondary Outcomes (1)

• acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours

  24 hours

Study Arms (2)

IV Nexium

ACTIVE COMPARATOR

Intravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours

Drug: Intravenous bolus injection of esomeprazole

Oral Nexium

ACTIVE COMPARATOR

Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours

Drug: Oral esomeprazole

Interventions

Intravenous bolus injection of esomeprazole DRUG

80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours

Also known as: IV Nexium

IV Nexium

Oral esomeprazole DRUG

40mg every 12 hours for 24 hours

Also known as: Oral Nexium

Oral Nexium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
• Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
• Absence of H. pylori infection
• Informed written consent

You may not qualify if:

• Known incompatibility to the study drugs;
• Known incompatibility and hypersensitivity to proton pump inhibitor
• H. pylori infection
• Recent H2RA or PPI use (within last 4 weeks)
• Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
• Pregnancy or lactation;
• Non-compliance e.g. mental subordination
• Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter
• Significant liver disease as PPI is metabolized by the cytochrome P-450 system
• Previous gastric surgery
• Chronic Aspirin user
• Presence of esophageal/ gastric varices
• Moribund patients, terminal malignancy \& patients with severe renal disease
• Patient unable to give written consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), China

Location

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

• James YW Lau, MD

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

CN (1)