Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01123031
Status:
WITHDRAWN
Last Update Posted:
2020-02-17
First Post:
2010-04-13
Brief Title:
Oral vs Intravenous and Proton Pump Inhibitor PPIfor Peptic Ulcer Bleeding PUB
Sponsor:
Changhua Christian Hospital
Organization:
Changhua Christian Hospital
Study Overview
Official Title:
Oral vs Intravenous Proton Pump InhibitorPPI in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated and the PI has left the institution
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 Laine and Javid et al found that oral PPI and IV PPI had a similar intragastric pH response in the past two years Therefore whether oral can replace IV in the management of peptic ulcer bleeding is the objective in this study
The investigators enrolled 130 patients with active bleeding or nonbleeding visible vesselsNBVV in this study They are randomly assigned as oral lansoprazole or IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the lansoprazole group N65 30 mg four times daily is given orally for three days Thereafter the patients receive 30 mg lansoprazole orally daily for two months In the nexium group 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 Laine and Javid et al found that oral PPI and IV PPI had a similar intragastric pH response in the past two years Therefore whether oral can replace IV in the management of peptic ulcer bleeding is the objective in this study
The investigators enrolled 130 patients with active bleeding or nonbleeding visible vesselsNBVV in this study They are randomly assigned as oral lansoprazole or IV nexium group All patients receive successful endoscopic therapy with heater probe or hemoclip placement
In the lansoprazole group N65 30 mg four times daily is given orally for three days Thereafter the patients receive 30 mg lansoprazole orally daily for two months In the nexium group 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 1 and is now recommended as the first hemostatic modality for these patients 1 2
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies two consensus statements and two meta-analysis 3-8 To sustain a high intragastric pH a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding In our study the investigators used 40 mg omeprazole intravenous bolus followed by 160 mgday continuously infusion for three days The mean intragastric pH rose to 60 one hour after the initial bolus of omeprazole in the omeprazole group it persisted around this value for the rest of the 24 hours7 The rebleeding rates were much lower in the PPI as compared with H2RA group Day 3 050 vs 850 p001 Day 14 250 vs 1250 p001 4
How about the route of PPI usage Oral or IV is the preferred route Laine et al used oral lansoprazole in patients with peptic ulcer bleeding9 They were randomly assigned to intravenous lansoprazole 90-mg bolus followed by 9-mgh infusion or oral lansoprazole 120-mg bolus followed by 30 mg every 3 hours A pH was recorded for 24 hours Mean pH rose above 6 after 2-3 hours of intravenous PPI and 3-4 hours of oral PPI They concluded that frequent oral PPI may be able to replace the currently recommended intravenous bolus plus infusion PPI therapy in patients with bleeding ulcers In one recent article Javid et al also proved that there was no significant difference among various PPIs omeprazole pantoprazole and rabeprazole given through different routes IV and oral routes on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer10 In our recent study the investigators have proved that oral rabeprazole and IV omeprazole are equally effective in preventing rebleeding 1378 in rabeprazole vs 1278 in omeprazole p01 in high-risk bleeding peptic ulcers11 All secondary outcomes between the two groups were similar including the amount of blood transfusion hospital stay need for surgery and mortality
The objectives of this study are to assess the outcomes of two different regimens of oral lansoprazole vs high dose of intravenous nexium after endoscopic therapy in patients with peptic ulcer bleeding
In the past few years adjuvant use of a high-dose proton pump inhibitor PPI after endoscopic therapy has been endorsed in some studies two consensus statements and two meta-analysis 3-8 To sustain a high intragastric pH a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding In our study the investigators used 40 mg omeprazole intravenous bolus followed by 160 mgday continuously infusion for three days The mean intragastric pH rose to 60 one hour after the initial bolus of omeprazole in the omeprazole group it persisted around this value for the rest of the 24 hours7 The rebleeding rates were much lower in the PPI as compared with H2RA group Day 3 050 vs 850 p001 Day 14 250 vs 1250 p001 4
How about the route of PPI usage Oral or IV is the preferred route Laine et al used oral lansoprazole in patients with peptic ulcer bleeding9 They were randomly assigned to intravenous lansoprazole 90-mg bolus followed by 9-mgh infusion or oral lansoprazole 120-mg bolus followed by 30 mg every 3 hours A pH was recorded for 24 hours Mean pH rose above 6 after 2-3 hours of intravenous PPI and 3-4 hours of oral PPI They concluded that frequent oral PPI may be able to replace the currently recommended intravenous bolus plus infusion PPI therapy in patients with bleeding ulcers In one recent article Javid et al also proved that there was no significant difference among various PPIs omeprazole pantoprazole and rabeprazole given through different routes IV and oral routes on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer10 In our recent study the investigators have proved that oral rabeprazole and IV omeprazole are equally effective in preventing rebleeding 1378 in rabeprazole vs 1278 in omeprazole p01 in high-risk bleeding peptic ulcers11 All secondary outcomes between the two groups were similar including the amount of blood transfusion hospital stay need for surgery and mortality
The objectives of this study are to assess the outcomes of two different regimens of oral lansoprazole vs high dose of intravenous nexium after endoscopic therapy in patients with peptic ulcer bleeding
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