Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Drug: Intravenous bolus injection of esomeprazole Drug: Oral esomeprazole Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2004
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


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
Drug: Intravenous bolus injection of esomeprazole
80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
Other Name: IV Nexium

Active Comparator: Oral Nexium
Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours
Drug: Oral esomeprazole
40mg every 12 hours for 24 hours
Other Name: Oral Nexium




Primary Outcome Measures :
  1. The primary measure of this study is the median gastric pH over 24-hour monitoring. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00164788


Locations
Layout table for location information
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong (SAR), China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: James YW Lau, MD Prince of Wales Hospital

Layout table for additonal information
Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164788    
Other Study ID Numbers: Ne_pH
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012
Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
24 hours pH monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action