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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164788
Recruitment Status : Terminated (No suitable patients and many patients refused the study)
First Posted : September 14, 2005
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date August 28, 2012
Study Start Date  ICMJE July 2004
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
The primary measure of this study is the median gastric pH over 24-hour monitoring. [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The primary measure of this study is the median gastric pH over 24-hour monitoring.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • A number of secondary measures are evaluated for detail comparison of 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Hemorrhage
Intervention  ICMJE
  • Drug: Intravenous bolus injection of esomeprazole
    80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
    Other Name: IV Nexium
  • Drug: Oral esomeprazole
    40mg every 12 hours for 24 hours
    Other Name: Oral Nexium
Study Arms  ICMJE
  • 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
    Intervention: Drug: Intravenous bolus injection of esomeprazole
  • Active Comparator: Oral Nexium
    Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours
    Intervention: Drug: Oral esomeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 27, 2012)
7
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
40
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164788
Other Study ID Numbers  ICMJE Ne_pH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Yun-wong Lau, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James YW Lau, MD Prince of Wales Hospital
PRS Account Chinese University of Hong Kong
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP