The Efficacy of Double Doses of Oral Esomeprazole in Preventing Rebleeding for Patients With Bleeding Peptic Ulcers (DDE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peptic Ulcer Bleeding |
Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
- recurrent bleeding [ Time Frame: within 28 days after the first bleeding event ] [ Designated as safety issue: Yes ]
- the length of hospitalization [ Time Frame: within 28 days after the first bleeidng event ] [ Designated as safety issue: No ]
- the amount of blood transfusion [ Time Frame: within 28 days after the first bleeding event ] [ Designated as safety issue: Yes ]
- major events such as surgery or transarterial embolization [ Time Frame: within 28 days after the first bleeding event ] [ Designated as safety issue: Yes ]
- the fading rate of major stigmata of recent hemorrhage [ Time Frame: within 3 days after the first bleeding event ] [ Designated as safety issue: Yes ]
- mortality [ Time Frame: within 28 days and 120 days after the first bleeding event ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Double oral dose
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days.
|
Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients with Rockall score >=6 are randomized into the double oral dose group and the regular oral dose group. Patients with Rockall score <6 are assigned to the control group. In the double oral dose group, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days. In the other two groups, patients receive 40 mg oral esomeprazole 40 mg once daily for 25 days. Other Name: Nexium
|
|
Active Comparator: Regular oral dose
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole twice daily for 25 days.
|
Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients with Rockall score >=6 are randomized into the double oral dose group and the regular oral dose group. Patients with Rockall score <6 are assigned to the control group. In the double oral dose group, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days. In the other two groups, patients receive 40 mg oral esomeprazole 40 mg once daily for 25 days. Other Name: Nexium
|
|
Active Comparator: Control group
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients receive 40 mg oral esomeprazole twice daily for 25 days.
|
Drug: esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)
Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients with Rockall score >=6 are randomized into the double oral dose group and the regular oral dose group. Patients with Rockall score <6 are assigned to the control group. In the double oral dose group, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days. In the other two groups, patients receive 40 mg oral esomeprazole 40 mg once daily for 25 days. Other Name: Nexium
|
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. The fading time of stigmata of recent hemorrhage 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 4.9 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 aimed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who received gastroscopy for melena, hematochezia, or hematemesis in whom bleeding peptic ulcers with major stigmata of recent hemorrhage are detected are consecutively enrolled. All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy.
Exclusion Criteria:
- Patients are excluded if they had tumor bleeding or ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction), warfarin use, failure to establish hemostasis under gastroscopy, or hypersensitivity to esomeprazole or any component of the formulation.
Contacts and Locations| Taiwan | |
| National Cheng Kung University Hospital | Recruiting |
| Tainan, Taiwan, 704 | |
| Contact: Hsiu-Chi Cheng, MD, PhD 886-6-2353535 ext 4733 teishuki@mail.ncku.edu.tw | |
| Study Director: | Bor-Shyang Sheu, MD | National Cheng-Kung University Hospital |
More Information
No publications provided
| Responsible Party: | National Cheng-Kung University Hospital |
| ClinicalTrials.gov Identifier: | NCT01591083 History of Changes |
| Other Study ID Numbers: | ER-100-008 |
| Study First Received: | May 2, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Cheng-Kung University Hospital:
|
Peptic ulcer rebleeding, double dose of esomeprazole |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Stomach Diseases Gastrointestinal Hemorrhage Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013