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 because the information has not been verified recently.
Verified May 2007 by Pamela Youde Nethersole Eastern Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT00471029
First received: May 8, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention Phase
Peptic Ulcer
Drug: esomeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compare Gastric Acid Suppression of Esomeprazole by Oral or Intravenous Administration - A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

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

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

Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: September 2007
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471029

Contacts
Contact: Simon K.H. Wong, MBChB, FRCSEd, FHKAM 852-25956416 wongkhmo@netvigator.com

Locations
China
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Simon KH Wong, MBChB       wongkhmo@netvigator.com   
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
Investigators
Principal Investigator: Simon K.H. Wong, MBChB, FRCSEd, FHKAM Pamela Youde Nethersole Hospital - Surgery
Study Chair: Michael K.W. Li, MD PYNEH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471029     History of Changes
Other Study ID Numbers: HKEC-2005-110
Study First Received: May 8, 2007
Last Updated: May 8, 2007
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Pamela Youde Nethersole Eastern Hospital:
pH study, peptic ulcer, proton pump inhibitor

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014