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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Pamela Youde Nethersole Eastern Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471029
First Posted: May 9, 2007
Last Update Posted: May 9, 2007
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.
Information provided by:
Pamela Youde Nethersole Eastern Hospital
May 8, 2007
May 9, 2007
May 9, 2007
September 2005
Not Provided
percentage of time intragstric pH > 6 and > 4 [ Time Frame: 24hours after endoscopy ]
Same as current
No Changes Posted
  • Median intragastric pH [ Time Frame: 24hours after endoscopy ]
  • time to attain intragastric pH 4 & 6 [ Time Frame: 24hours after endoscopy ]
Same as current
Not Provided
Not Provided
 
Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer
Compare Gastric Acid Suppression of Esomeprazole by Oral or Intravenous Administration - A Randomized Trial
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.

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.

Protocol:

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peptic Ulcer
Drug: esomeprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
September 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00471029
HKEC-2005-110
Yes
Not Provided
Not Provided
Not Provided
Pamela Youde Nethersole Eastern Hospital
Not Provided
Principal Investigator: Simon K.H. Wong, MBChB, FRCSEd, FHKAM Pamela Youde Nethersole Hospital - Surgery
Study Chair: Michael K.W. Li, MD PYNEH
Pamela Youde Nethersole Eastern Hospital
May 2007

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