Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01591083
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2012-05-02
Brief Title:
The Efficacy of Double Doses of Oral Esomeprazole in Preventing Rebleeding for Patients With Bleeding Peptic Ulcers
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
The Studies of the Pathophysiologic Mechanisms of Poor Ulcer Healing Clinical Improvement to the High Ulcer Rebleeding Rate for Patients With Comorbid Illnesses
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
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:
DDE
Brief Summary:
Patients with comorbidities have an increased risk of ulcer re-bleeding especially within the 14 days after first bleeding event Three-day high dose esomeprazole infusion can prevent peptic ulcer rebleeding after endoscopic therapy However the optimal dose of oral esomeprazole is uncertain especially for high risky patients This study is to test whether a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with Rockall score 6 Additionally the second aim of this prospective study was to identify the selection criteria to predict poor fading and residual major stigmata of recent hemorrhage SRH or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI infusion
Detailed Description:
Peptic ulcer bleeding is a common and lethal disease and the recurrent bleeding is an independent risk factor leading to the mortality The recurrent bleeding of peptic ulcers is related to the presence of the stigmata of recent hemorrhage SRH The fading time of SRH is around 3 to 6 days therefore the recurrent bleeding develops within 2-3 days after first bleeding episode The aim of acute treatment of peptic ulcer bleeding is to reduce recurrent bleeding by using anti-secretory drugs Accordingly the common duration of omeprazole infusion is applied as 3 days after the endoscopic therapy Moreover recurrent bleeding is also positively linked with the presence of co-morbidities In general patients with underlying medical co-morbidities have increased rates of recurrent bleeding and longer duration in risk of recurrent bleeding than those without co-morbidity
Nonetheless even with continuous infusion of omeprazole for 3 days recurrent bleeding rates remain high in certain patients such as those with the presence of underlying medical co-morbidities Moreover the duration of peptic ulcer recurrent bleeding is elongated up to the 14th day after the first bleeding episode in patients with co-morbidities To prevent recurrent bleeding in such high risk patients we showed therapeutic benefit for the prolonged course of 7-day low-dose intravenous omeprazole which exerts better recurrent bleeding control than just 3-day high-dose infusion
The intragastric 24-h median pH is 49 in patients with oral 40 mg omeprazole once daily which is significantly higher than baseline pH in healthy subjects However gastric acid secretion is not suppressed completely during 24 hours with oral omeprazole 40 mg once daily Several studies have shown that oral high-dose PPI is equally effective in raising the intragastric pH more than 6 and reducing recurrent bleeding as the intravenous route
Hence this study aims to test whether a higher dose of oral esomeprazole which is more effective in maintaining favorable intragastric pH could effectively reduce ulcer rebleeding in patients with comorbidities This data will show the originality and clinical importance of a higher dose of oral esomeprazole for such high-risk patients with comorbidities with peptic ulcer bleeding
Additionally endoscopic treatment plus a 3-day intravenous proton pump inhibitor infusion is the standard protocol for treatment of peptic ulcer bleeding Moreover several studies have shown that PPI treatment prior to endoscopy could decrease the presentation of SRH and the need of endoscopic hemostasis However there are insufficient data to validate the efficacy of such standard treatment to fade the SRH Therefore several studies looked at the efficacy of routine second-look endoscopy defined as scheduled repeat endoscopy after primary endoscopic hemostasis in patients at high risk of rebleeding However the role of second-look endoscopy and the selection criteria for patients who require second-look endoscopy remain uncertain There is a pressing need to elucidate the role of second-look endoscopy in patients with peptic ulcer bleeding after high-dose PPI infusion
Hence the second aim of this prospective study is to identify the selection criteria to predict poor fading and residual major SRH or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI infusion This data will show the originality and clinical importance to identify the risk factors to predict poor fading of SRH after current standard treatment and the patients who are indicated to receive second-look endoscopy
Nonetheless even with continuous infusion of omeprazole for 3 days recurrent bleeding rates remain high in certain patients such as those with the presence of underlying medical co-morbidities Moreover the duration of peptic ulcer recurrent bleeding is elongated up to the 14th day after the first bleeding episode in patients with co-morbidities To prevent recurrent bleeding in such high risk patients we showed therapeutic benefit for the prolonged course of 7-day low-dose intravenous omeprazole which exerts better recurrent bleeding control than just 3-day high-dose infusion
The intragastric 24-h median pH is 49 in patients with oral 40 mg omeprazole once daily which is significantly higher than baseline pH in healthy subjects However gastric acid secretion is not suppressed completely during 24 hours with oral omeprazole 40 mg once daily Several studies have shown that oral high-dose PPI is equally effective in raising the intragastric pH more than 6 and reducing recurrent bleeding as the intravenous route
Hence this study aims to test whether a higher dose of oral esomeprazole which is more effective in maintaining favorable intragastric pH could effectively reduce ulcer rebleeding in patients with comorbidities This data will show the originality and clinical importance of a higher dose of oral esomeprazole for such high-risk patients with comorbidities with peptic ulcer bleeding
Additionally endoscopic treatment plus a 3-day intravenous proton pump inhibitor infusion is the standard protocol for treatment of peptic ulcer bleeding Moreover several studies have shown that PPI treatment prior to endoscopy could decrease the presentation of SRH and the need of endoscopic hemostasis However there are insufficient data to validate the efficacy of such standard treatment to fade the SRH Therefore several studies looked at the efficacy of routine second-look endoscopy defined as scheduled repeat endoscopy after primary endoscopic hemostasis in patients at high risk of rebleeding However the role of second-look endoscopy and the selection criteria for patients who require second-look endoscopy remain uncertain There is a pressing need to elucidate the role of second-look endoscopy in patients with peptic ulcer bleeding after high-dose PPI infusion
Hence the second aim of this prospective study is to identify the selection criteria to predict poor fading and residual major SRH or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI infusion This data will show the originality and clinical importance to identify the risk factors to predict poor fading of SRH after current standard treatment and the patients who are indicated to receive second-look endoscopy
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