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Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer (NPH)

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. Identifier: NCT00471029
Recruitment Status : Unknown
Verified May 2007 by Pamela Youde Nethersole Eastern Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2007
Last Update Posted : May 9, 2007
Information provided by:
Pamela Youde Nethersole Eastern Hospital

Brief Summary:
The purpose of this study is to compare the gastric acid suppression profile among different regimen (Oral Vs Intravenous)of administration of proton pump inhibitor - Esomeprazole by 24hours intragastric pH monitoring.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: esomeprazole Phase 4

Detailed Description:

Peptic ulcer bleeding is a common medical emergency. Although primary hemostasis can be achieved by endoscopic hemostasis in more than 90% of cases, rebleeding during the first 72 hours is still common. The use of secretory inhibitors in ulcer bleeding had theoretical benefit in preventing rebleeding. In vitro, platelet aggregation and disaggregation, coagulation and fibrinolysis are strongly dependent on intra-gastric pH. When pH falls below 6.0, platelet disaggregation takes place and below 4.0, fibrin clots dissolved. Pharmacological studies have clearly shown that primed proton-pump inhibitor (PPI) infusion is superior to H2-receptor blocler (H2B) injection or infusion in maintaining high intra-gastric pH. Randomized trials had demonstrated the advantage of adjuvant use of intravenous or oral PPI in reducing rebleeding as compared to placebo. However, as Asian subjects generally have lower body weight and acid output than Caucasians, the dosage of PPI required for prevent rebleeding may be different. Lin et al had demonstrated that in an Asian population study, in order to show a significant clinical effect in prevent peptic ulcer rebleeding after endoscopic hemostasis, at least a 30% difference in duration in maintaining an intragastric pH >6 must be achieved. As there is substantial cost implication of routine use of high dose intravenous PPI infusion (80mg bolus + 8mg/hour for 72 hours, cost ~HKD$1100) against high dose oral esomeprazole (40mg BD for 3 days, cost ~HKD$60), the optimal doses and routes of administration of PPI in achieving effective acid suppression is needed to be clearly defined.


Patients presented with bleeding peptic ulcers (melena, hememtesis) will undergo endoscopy. If clean base peptic ulcer which dos not require endoscopic treatment is diagnosed, consented patients will randomly allocated into 2 groups using sealed envelopes containing a therapeutic option derived from a randomized table.

  1. Esomeprazole infusion (80mg bolus then 8mg/hour) (192mg/d)
  2. Esomeprazole Tablet oral 40mg 12 hourly (80mg/d)

A pH electrode with internal reference (Synetic) was inserted transnasally and positioned 10cm below the cardia. It was calibrated before and after the pH recording with standard buffer solutions of pH 7.00 and pH 1.00. The electrode was connected to a data logger (Mircodigitrapper, Synetic). At the end of 24hours recording, the data were transfer to a personal computer for analysis. Medication will be given after insertion of intra-gastric pH monitor probe.

Outcome measures Primary Outcome: total % Time pH > 6 & 4 Secondary outcome: Median intragastric pH & Time to reach pH 4 and 6

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare Gastric Acid Suppression of Esomeprazole by Oral or Intravenous Administration - A Randomized Trial
Study Start Date : September 2005
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Primary Outcome Measures :
  1. percentage of time intragstric pH > 6 and > 4 [ Time Frame: 24hours after endoscopy ]

Secondary Outcome Measures :
  1. Median intragastric pH [ Time Frame: 24hours after endoscopy ]
  2. time to attain intragastric pH 4 & 6 [ Time Frame: 24hours after endoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with non-bleeding peptic ulcer which do not require endoscopic therapy.
  2. Chinese, Age ³18 and <90
  3. Provision of an informed written consent signed by the patient.

Exclusion Criteria:

  1. Treatment of antisecretory drugs during the preceding 4 weeks
  2. The present inter-current ulcer complication (gastric outlet obstruction or ulcer perforation)
  3. Presence of esophageal / gastric varices
  4. aspirin or NSAID user
  5. Pregnancy
  6. Age <18 or >90
  7. Moribund patients, patients with severe liver or renal disease
  8. Known sensitivity to proton pump inhibitors
  9. Previous gastric surgery (except simple patch repair)
  10. Patient unable to give written consent
  11. Special population, e.g. prisoner, mentally disabled, investigators’ student or employees

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471029

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Contact: Simon K.H. Wong, MBChB, FRCSEd, FHKAM 852-25956416

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Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Simon KH Wong, MBChB   
Principal Investigator: Simon KH Wong, MBChB         
Sub-Investigator: Michael KW Li, MD         
Sub-Investigator: Geroge PC Yang, MBBS         
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
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Principal Investigator: Simon K.H. Wong, MBChB, FRCSEd, FHKAM Pamela Youde Nethersole Hospital - Surgery
Study Chair: Michael K.W. Li, MD PYNEH

Layout table for additonal information Identifier: NCT00471029     History of Changes
Other Study ID Numbers: HKEC-2005-110
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: May 9, 2007
Last Verified: May 2007
Keywords provided by Pamela Youde Nethersole Eastern Hospital:
pH study, peptic ulcer, proton pump inhibitor
Additional relevant MeSH terms:
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Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action