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The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.
Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole active treatment | Experimental | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
|
| Cimetidine active treatment | Active Comparator | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase | Criteria for a clinically significant upper GI bleeding as:
During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline. | 1-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase | Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinyu Qin | Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baotou | China | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29638148 | Derived | Lou W, Xia Y, Xiang P, Zhang L, Yu X, Lim S, Xu M, Zhao L, Rydholm H, Traxler B, Qin X. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine. Curr Med Res Opin. 2018 Aug;34(8):1449-1455. doi: 10.1080/03007995.2018.1464132. Epub 2018 Apr 20. |
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32 patients were not randomised to treatment due to eligibility criteria not being fulfilled.
Overall, 343 patients were enrolled from 27 centres in China. The first patient entered the study on 15 July 2014 and the last patient completed the study on 18 February 2016.
Of the 343 patients enrolled into the study, 311 (90.7%) patients were randomised to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days |
| FG001 | Cimetidine | iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Among 311 randomised patients, 300 patients received randomised treatment: 147 patients in the esomeprazole treatment group and 153 patients in the cimetidine treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole | iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days |
| BG001 | Cimetidine | iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase | Criteria for a clinically significant upper GI bleeding as:
During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline. | Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated. | Posted | Number | % of participants | 1-14 days |
|
AEs will be collected from the time of the first administration of IMP until the end of follow-up, up to 15 days. SAEs will be collected from signed inform consent until the end of follow-up, up to 15 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cimetidine | iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry Traxler | AstraZeneca | barry.traxler@astrazeneca.com |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D002927 | Cimetidine |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Cimetidine | Drug | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
|
|
| 1-14 days |
| Changsha |
| China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Fuzhou | China |
| Research Site | Guangzhou | China |
| Research Site | Guilin | China |
| Research Site | Haikou | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Shenzhen | China |
| Research Site | Tianjin | China |
| Research Site | Ürümqi | China |
| Research Site | Xi'an | China |
| Research Site | Zhanjiang | China |
| Withdrawal by Subject |
|
| Not treated |
|
| Investigator's misjudgement |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG000 |
| Esomeprazole |
iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days |
| OG001 | Cimetidine | iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days |
|
|
|
| Secondary | Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase | Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as:
| Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated. | Posted | Number | proportion of participants | 1-14 days |
|
|
|
| 12 |
| 153 |
| 88 |
| 153 |
| EG001 | Esomeprazole | iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days | 14 | 147 | 85 | 147 |
| Cardiogenic shock | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral circulatory failure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006146 | Guanidines |
| D000578 | Amidines |
| D007093 | Imidazoles |
| D001393 | Azoles |