Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164788
Status:
TERMINATED
Last Update Posted:
2012-08-28
First Post:
2005-09-09
Brief Title:
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No suitable patients and many patients refused the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus followed by 8mgh 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None