Trial Outcomes & Findings for A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer (NCT NCT00251979)
NCT ID: NCT00251979
Last Updated: 2011-06-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1312 participants
Primary outcome timeframe
Within 72 hours
Results posted on
2011-06-17
Participant Flow
Participant milestones
| Measure |
Esomeprazole
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Overall Study
STARTED
|
375
|
389
|
|
Overall Study
COMPLETED
|
337
|
349
|
|
Overall Study
NOT COMPLETED
|
38
|
40
|
Reasons for withdrawal
| Measure |
Esomeprazole
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Adverse Event
|
11
|
17
|
|
Overall Study
Withdrawal by Subject
|
13
|
7
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Death
|
3
|
5
|
Baseline Characteristics
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Baseline characteristics by cohort
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Total
n=764 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
193 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 72 hoursOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
|
22 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Within 7 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Clinically Significant Rebleeding Within 7 Days
|
27 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Clinically Significant Rebleeding Within 30 Days
|
29 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Within 72 hoursOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Death Within 72 Hours
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Death Within 30 Days
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Death Related to Rebleeding Within 30 Days as Judged by the EpC
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 72 hoursOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Requirement for Surgery Within 72 Hours
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Requirement for Surgery Within 30 Days
|
10 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Within 72 hoursOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Requirement for Endoscopic Re-treatment Within 72 Hours
|
16 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Requirement for Endoscopic Re-treatment Within 30 Days
|
24 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Within 72 hoursOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Number of Blood Units Transfused Within 72 Hours
|
492 blood units
|
738 blood units
|
SECONDARY outcome
Timeframe: within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Number of Blood Units Transfused Within 30 Days
|
589 blood units
|
935 blood units
|
SECONDARY outcome
Timeframe: Within 30 daysOutcome measures
| Measure |
Esomeprazole
n=375 Participants
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 Participants
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
|
284 days
|
500 days
|
Adverse Events
Esomeprazole
Serious events: 61 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo
Serious events: 68 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esomeprazole
n=375 participants at risk
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 participants at risk
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.27%
1/375
|
0.51%
2/389
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA PANCREAS
|
0.00%
0/375
|
0.26%
1/389
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.27%
1/375
|
0.00%
0/389
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/375
|
0.77%
3/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN GASTRIC NEOPLASM
|
0.00%
0/375
|
0.26%
1/389
|
|
Cardiac disorders
BRADYCARDIA
|
0.27%
1/375
|
0.00%
0/389
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.27%
1/375
|
0.00%
0/389
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.27%
1/375
|
0.00%
0/389
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.27%
1/375
|
0.00%
0/389
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.27%
1/375
|
0.00%
0/389
|
|
Metabolism and nutrition disorders
DISCOMFORT
|
0.27%
1/375
|
0.00%
0/389
|
|
Injury, poisoning and procedural complications
DISLOCATION OF JOINT PROSTHESIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
DUODENAL PERFORATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
4.3%
16/375
|
5.4%
21/389
|
|
Gastrointestinal disorders
DUODENAL ULCER PERFORATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
FATIGUE
|
0.27%
1/375
|
0.00%
0/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.80%
3/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
1.9%
7/375
|
3.3%
13/389
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
GASTROENTERITIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Congenital, familial and genetic disorders
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.27%
1/375
|
0.26%
1/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL STROMAL TUMOUR
|
0.27%
1/375
|
0.00%
0/389
|
|
Metabolism and nutrition disorders
GOUT
|
0.53%
2/375
|
0.26%
1/389
|
|
Musculoskeletal and connective tissue disorders
GOUTY ARTHRITIS
|
0.00%
0/375
|
0.77%
3/389
|
|
Musculoskeletal and connective tissue disorders
HAEMOGLOBIN DECREASED
|
0.00%
0/375
|
0.26%
1/389
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.27%
1/375
|
0.00%
0/389
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.27%
1/375
|
0.00%
0/389
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
LUNG INFECTION
|
0.27%
1/375
|
0.00%
0/389
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
MELAENA
|
0.53%
2/375
|
0.00%
0/389
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.1%
4/375
|
1.3%
5/389
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
PEPTIC ULCER PERFORATION
|
0.00%
0/375
|
0.26%
1/389
|
|
Nervous system disorders
PERIPHERAL NERVE LESION
|
0.27%
1/375
|
0.00%
0/389
|
|
Gastrointestinal disorders
PERITONITIS
|
0.00%
0/375
|
0.26%
1/389
|
|
Vascular disorders
PHLEBITIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.27%
1/375
|
0.00%
0/389
|
|
Infections and infestations
PNEUMONIA
|
0.27%
1/375
|
0.00%
0/389
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.00%
0/375
|
0.26%
1/389
|
|
Nervous system disorders
PRESYNCOPE
|
0.27%
1/375
|
0.00%
0/389
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/375
|
0.51%
2/389
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/375
|
0.26%
1/389
|
|
Respiratory, thoracic and mediastinal disorders
PYREXIA
|
0.27%
1/375
|
0.00%
0/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/375
|
0.26%
1/389
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.27%
1/375
|
0.00%
0/389
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/375
|
0.26%
1/389
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.27%
1/375
|
0.26%
1/389
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.27%
1/375
|
0.00%
0/389
|
|
Vascular disorders
SHOCK
|
0.27%
1/375
|
0.00%
0/389
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.27%
1/375
|
0.00%
0/389
|
|
Nervous system disorders
SYNCOPE
|
0.27%
1/375
|
0.00%
0/389
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTICULAR CANCER METASTATIC
|
0.00%
0/375
|
0.26%
1/389
|
|
Vascular disorders
THROMBOSIS
|
0.27%
1/375
|
0.00%
0/389
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/375
|
0.26%
1/389
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/375
|
0.26%
1/389
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.27%
1/375
|
—
0/0
|
|
Eye disorders
UVEITIS
|
0.27%
1/375
|
—
0/0
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.27%
1/375
|
—
0/0
|
Other adverse events
| Measure |
Esomeprazole
n=375 participants at risk
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
Placebo
n=389 participants at risk
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/375
|
3.3%
13/389
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.6%
6/375
|
2.6%
10/389
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/375
|
1.5%
6/389
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.7%
10/375
|
3.9%
15/389
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/375
|
1.5%
6/389
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.9%
7/375
|
0.00%
0/389
|
|
Nervous system disorders
DIZZINESS
|
1.6%
6/375
|
1.3%
5/389
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/375
|
2.1%
8/389
|
|
Nervous system disorders
HEADACHE
|
2.1%
8/375
|
2.8%
11/389
|
|
Vascular disorders
HYPERTENSION
|
1.6%
6/375
|
1.8%
7/389
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/375
|
1.8%
7/389
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/375
|
2.3%
9/389
|
|
Gastrointestinal disorders
NAUSEA
|
2.9%
11/375
|
2.6%
10/389
|
|
Vascular disorders
PHLEBITIS
|
2.4%
9/375
|
0.00%
0/389
|
|
Skin and subcutaneous tissue disorders
PYREXIA
|
4.5%
17/375
|
3.6%
14/389
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.9%
7/375
|
2.1%
8/389
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed.
- Publication restrictions are in place
Restriction type: OTHER