NCT00164788

A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DRUG	Intravenous bolus injection of esomeprazole	80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
DRUG	Oral esomeprazole	40mg every 12 hours for 24 hours

Timeline

• Start date: 2004-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2005-09-14
• Last updated: 2012-08-28

Locations

1 site across 1 country: China