Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01275937
Status:
UNKNOWN
Last Update Posted:
2011-08-12
First Post:
2011-01-12
Brief Title:
A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
Status:
UNKNOWN
Status Verified Date:
2011-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality Endoscopic therapy significantly reduces further bleeding surgery and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies However low dose of PPI has also been supported in the management of these patients
The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in this study They are randomly assigned as 40 mgday or 160mgday IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the low dose group N65 40 mg IV Nexium daily is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months In the large dose group N65 160 mgday continuous infusion is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months
The primary end point is recurrent bleeding before discharge and within 14 days At day 14 volume of blood transfused number of surgeries performed and the mortality rates of the two groups are compared as well
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies However low dose of PPI has also been supported in the management of these patients
The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in this study They are randomly assigned as 40 mgday or 160mgday IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the low dose group N65 40 mg IV Nexium daily is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months In the large dose group N65 160 mgday continuous infusion is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months
The primary end point is recurrent bleeding before discharge and within 14 days At day 14 volume of blood transfused number of surgeries performed and the mortality rates of the two groups are compared as well
Detailed Description:
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality Endoscopic therapy significantly reduces further bleeding surgery and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies However low dose of PPI has also been supported in the management of these patients
We enroll 130 patients with active bleeding or nonbleeding visible vessels in this study They are randomly assigned as 40 mgday or 160mgday IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the low dose group N65 40 mg IV Nexium daily is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months In the large dose group N65 160 mgday continuous infusion is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months
The primary end point is recurrent bleeding before discharge and within 14 days At day 14 volume of blood transfused number of surgeries performed and the mortality rates of the two groups are compared as well
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies However low dose of PPI has also been supported in the management of these patients
We enroll 130 patients with active bleeding or nonbleeding visible vessels in this study They are randomly assigned as 40 mgday or 160mgday IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the low dose group N65 40 mg IV Nexium daily is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months In the large dose group N65 160 mgday continuous infusion is given for three days Thereafter the patients receive 40 mg nexium orally daily for two months
The primary end point is recurrent bleeding before discharge and within 14 days At day 14 volume of blood transfused number of surgeries performed and the mortality rates of the two groups are compared as well
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