A Study to Prevent Rebleeding After Initial Successful Pr... | NCT00251979

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole	Drug

Measure	Description	Time Frame
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo		Within 72 hours

Measure	Description	Time Frame
Clinically Significant Rebleeding Within 7 Days		Within 7 days
Clinically Significant Rebleeding Within 30 Days		Within 30 days
Death Within 72 Hours

Name	Affiliation	Role
AstraZeneca Nexium Medical Sciences Director	AstraZeneca	Study Director
Joseph Sung, MD	Chinese University of Hong Kong	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Braunau/Inn			Austria
Research Site

PubMed Identifier	Type	Citation	Retractions
28070941	Derived	Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.
21181319	Derived	Kuipers EJ, Sung JJ, Barkun A, Mossner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.

ID	Title	Description
FG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
FG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

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

Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo

Posted

Number

Participants

Within 72 hours

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001389

Title

Denominators

Categories

Title	Measurements
	OG00022 OG00140

Secondary

Clinically Significant Rebleeding Within 7 Days

Posted

Number

Participants

Within 7 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Clinically Significant Rebleeding Within 30 Days

Posted

Number

Participants

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Death Within 72 Hours

Posted

Number

Participants

Within 72 hours

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Death Within 30 Days

Posted

Number

Participants

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Death Related to Rebleeding Within 30 Days as Judged by the EpC

Posted

Number

Participants

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375

Secondary

Requirement for Surgery Within 72 Hours

Posted

Number

Participants

Within 72 hours

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Requirement for Surgery Within 30 Days

Posted

Number

Participants

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Requirement for Endoscopic Re-treatment Within 72 Hours

Posted

Number

Participants

Within 72 hours

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Requirement for Endoscopic Re-treatment Within 30 Days

Posted

Number

Participants

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Number of Blood Units Transfused Within 72 Hours

Posted

Number

blood units

Within 72 hours

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Number of Blood Units Transfused Within 30 Days

Posted

Number

blood units

within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375 OG001

Secondary

Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period

Posted

Number

days

Within 30 days

ID	Title	Description
OG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
OG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days

Units	Counts
Participants	OG000375

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0012 affected389 at risk
ACUTE PSYCHOSIS	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
ADENOCARCINOMA PANCREAS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0013 affected389 at risk
BENIGN GASTRIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
DISCOMFORT	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
DISLOCATION OF JOINT PROSTHESIS	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
DUODENAL PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected375 at risk EG00121 affected389 at risk
DUODENAL ULCER PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
ERYSIPELAS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
FATIGUE	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 affected375 at risk EG0011 affected389 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected375 at risk EG00113 affected389 at risk
GASTRIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0011 affected389 at risk
GASTROINTESTINAL STROMAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected375 at risk EG0011 affected389 at risk
GOUTY ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0013 affected389 at risk
HAEMOGLOBIN DECREASED	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
LUNG INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
MELAENA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected375 at risk EG0010 affected389 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected375 at risk EG0015 affected389 at risk
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
PEPTIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
PERIPHERAL NERVE LESION	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PERITONITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
PHLEBITIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PNEUMOTHORAX TRAUMATIC	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0012 affected389 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
PYREXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0011 affected389 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
SHOCK	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
SYNCOPE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
TESTICULAR CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected389 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0011 affected389 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Non-systematic Assessment	EG0001 affected375 at risk EG0010 affected0 at risk
UVEITIS	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected0 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected375 at risk EG0010 affected0 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG00113 affected389 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected375 at risk EG00110 affected389 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0016 affected389 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected375 at risk EG00115 affected389 at risk
CYSTITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0016 affected389 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected375 at risk EG0010 affected389 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected375 at risk EG0015 affected389 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0018 affected389 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected375 at risk EG00111 affected389 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected375 at risk EG0017 affected389 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0017 affected389 at risk
INSOMNIA	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected375 at risk EG0019 affected389 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected375 at risk EG00110 affected389 at risk
PHLEBITIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected375 at risk EG0010 affected389 at risk
PYREXIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected375 at risk EG00114 affected389 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0007 affected375 at risk EG0018 affected389 at risk

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
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

ID	Title	Description
BG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
BG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Esomeprazole	Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days			61		87	375
EG001	Placebo	Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days			68		129	389