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

NCT ID: NCT00164788

Last Updated: 2012-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2011-01-31

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.

Detailed 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.

Conditions

Gastrointestinal Hemorrhage

Keywords

24 hours pH monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Nexium

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

Group Type: ACTIVE_COMPARATOR

Intravenous bolus injection of esomeprazole

Intervention Type: DRUG

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

Oral Nexium

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

Group Type: ACTIVE_COMPARATOR

Oral esomeprazole

Intervention Type: DRUG

40mg every 12 hours for 24 hours

Interventions

Intravenous bolus injection of esomeprazole

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

Intervention Type: DRUG

Oral esomeprazole

40mg every 12 hours for 24 hours

Intervention Type: DRUG

Other Intervention Names

IV Nexium; Oral Nexium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James YW Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), , China

Countries

China

Other Identifiers

Ne_pH

Identifier Type: -

Identifier Source: org_study_id