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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

A Randomized Comparison of High Dose Oral to Intravenous Esomeprazole in Patients After Endoscopic Control to Their Bleeding Peptic Ulcers: an Intra-gastric pH Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00164788
• Other study ID #: Ne_pH
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: August 27, 2012
• Start date: July 2004
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome [Lau JY N Engl J Med 2000]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Drug:
• Intravenous bolus injection of esomeprazole
80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
• Oral esomeprazole
40mg every 12 hours for 24 hours

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong (SAR)

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary measure of this study is the median gastric pH over 24-hour monitoring.		24 hours	No
Secondary	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	No