- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164788
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
August 27, 2012 updated by: James Yun-wong Lau, Chinese University of Hong Kong
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong (SAR), China
- Endoscopy Center, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
Other Names:
|
Active Comparator: Oral Nexium
Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours
|
40mg every 12 hours for 24 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary measure of this study is the median gastric pH over 24-hour monitoring.
Time Frame: 24 hours
|
24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James YW Lau, MD, Prince of Wales Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
August 28, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ne_pH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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