Clinical trial NCT00164788: A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastrointestinal Hemorrhage
Keywords: 24 hours pH monitoring
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The primary measure of this study is the median gastric pH over 24-hour monitoring.
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hong Kong (SAR)
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: James YW Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: