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A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00251979
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : June 17, 2011
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Prevention
Condition Gastrointestinal Hemorrhage
Intervention Drug: Esomeprazole
Enrollment 1312

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Period Title: Overall Study
Started 375 [1] 389 [1]
Completed 337 349
Not Completed 38 40
Reason Not Completed
Protocol Violation             3             5
Adverse Event             11             17
Withdrawal by Subject             13             7
Lost to Follow-up             8             6
Death             3             5
[1]
ITT population
Arm/Group Title Esomeprazole Placebo Total
Hide Arm/Group Description Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days Total of all reporting groups
Overall Number of Baseline Participants 375 389 764
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 389 participants 764 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
182
  48.5%
210
  54.0%
392
  51.3%
>=65 years
193
  51.5%
179
  46.0%
372
  48.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 389 participants 764 participants
Female
121
  32.3%
121
  31.1%
242
  31.7%
Male
254
  67.7%
268
  68.9%
522
  68.3%
1.Primary Outcome
Title Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
22 40
2.Secondary Outcome
Title Clinically Significant Rebleeding Within 7 Days
Hide Description [Not Specified]
Time Frame Within 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
27 50
3.Secondary Outcome
Title Clinically Significant Rebleeding Within 30 Days
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
29 53
4.Secondary Outcome
Title Death Within 72 Hours
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
1 0
5.Secondary Outcome
Title Death Within 30 Days
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
3 8
6.Secondary Outcome
Title Death Related to Rebleeding Within 30 Days as Judged by the EpC
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
2 3
7.Secondary Outcome
Title Requirement for Surgery Within 72 Hours
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
5 9
8.Secondary Outcome
Title Requirement for Surgery Within 30 Days
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
10 21
9.Secondary Outcome
Title Requirement for Endoscopic Re-treatment Within 72 Hours
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
16 32
10.Secondary Outcome
Title Requirement for Endoscopic Re-treatment Within 30 Days
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: Participants
24 45
11.Secondary Outcome
Title Number of Blood Units Transfused Within 72 Hours
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: blood units
492 738
12.Secondary Outcome
Title Number of Blood Units Transfused Within 30 Days
Hide Description [Not Specified]
Time Frame within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: blood units
589 935
13.Secondary Outcome
Title Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
Hide Description [Not Specified]
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
Overall Number of Participants Analyzed 375 389
Measure Type: Number
Unit of Measure: days
284 500
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
All-Cause Mortality
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   61   68 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/375 (0.27%)  2/389 (0.51%) 
ANGINA PECTORIS  1  1/375 (0.27%)  0/389 (0.00%) 
ANGINA UNSTABLE  1  1/375 (0.27%)  0/389 (0.00%) 
ATRIAL FIBRILLATION  1  0/375 (0.00%)  3/389 (0.77%) 
BRADYCARDIA  1  1/375 (0.27%)  0/389 (0.00%) 
CARDIAC FAILURE  1  1/375 (0.27%)  0/389 (0.00%) 
MYOCARDIAL INFARCTION  1  4/375 (1.07%)  5/389 (1.29%) 
Congenital, familial and genetic disorders     
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC  1  0/375 (0.00%)  1/389 (0.26%) 
Eye disorders     
UVEITIS  1  1/375 (0.27%)  0/0 
Gastrointestinal disorders     
COLONIC POLYP  1  0/375 (0.00%)  1/389 (0.26%) 
CONSTIPATION  1  0/375 (0.00%)  1/389 (0.26%) 
DUODENAL PERFORATION  1  0/375 (0.00%)  1/389 (0.26%) 
DUODENAL ULCER HAEMORRHAGE  1  16/375 (4.27%)  21/389 (5.40%) 
DUODENAL ULCER PERFORATION  1  0/375 (0.00%)  1/389 (0.26%) 
GASTRIC ULCER HAEMORRHAGE  1  7/375 (1.87%)  13/389 (3.34%) 
GASTRIC ULCER PERFORATION  1  0/375 (0.00%)  1/389 (0.26%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/375 (0.27%)  1/389 (0.26%) 
MELAENA  1  2/375 (0.53%)  0/389 (0.00%) 
PANCREATITIS ACUTE  1  0/375 (0.00%)  1/389 (0.26%) 
PEPTIC ULCER PERFORATION  1  0/375 (0.00%)  1/389 (0.26%) 
PERITONITIS  1  0/375 (0.00%)  1/389 (0.26%) 
RECTAL HAEMORRHAGE  1  1/375 (0.27%)  0/389 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/375 (0.27%)  0/389 (0.00%) 
Infections and infestations     
ERYSIPELAS  1  0/375 (0.00%)  1/389 (0.26%) 
FATIGUE  1  1/375 (0.27%)  0/389 (0.00%) 
GASTROENTERITIS  1  1/375 (0.27%)  0/389 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/375 (0.27%)  0/389 (0.00%) 
LUNG INFECTION  1  1/375 (0.27%)  0/389 (0.00%) 
PNEUMONIA  1  1/375 (0.27%)  0/389 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/375 (0.27%)  0/389 (0.00%) 
URINARY TRACT INFECTION  1  0/375 (0.00%)  1/389 (0.26%) 
Injury, poisoning and procedural complications     
DISLOCATION OF JOINT PROSTHESIS  1  1/375 (0.27%)  0/389 (0.00%) 
HIP FRACTURE  1  1/375 (0.27%)  0/389 (0.00%) 
PNEUMOTHORAX TRAUMATIC  1  0/375 (0.00%)  1/389 (0.26%) 
SUBDURAL HAEMORRHAGE  1  1/375 (0.27%)  0/389 (0.00%) 
Metabolism and nutrition disorders     
DIABETES MELLITUS  1  1/375 (0.27%)  0/389 (0.00%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  1/375 (0.27%)  0/389 (0.00%) 
DISCOMFORT  1  1/375 (0.27%)  0/389 (0.00%) 
GOUT  1  2/375 (0.53%)  1/389 (0.26%) 
HYPONATRAEMIA  1  0/375 (0.00%)  1/389 (0.26%) 
Musculoskeletal and connective tissue disorders     
GOUTY ARTHRITIS  1  0/375 (0.00%)  3/389 (0.77%) 
HAEMOGLOBIN DECREASED  1  0/375 (0.00%)  1/389 (0.26%) 
OSTEOLYSIS  1  1/375 (0.27%)  0/389 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ADENOCARCINOMA PANCREAS  1  0/375 (0.00%)  1/389 (0.26%) 
BENIGN GASTRIC NEOPLASM  1  0/375 (0.00%)  1/389 (0.26%) 
GASTRIC CANCER  1  3/375 (0.80%)  1/389 (0.26%) 
GASTROINTESTINAL STROMAL TUMOUR  1  1/375 (0.27%)  0/389 (0.00%) 
RECTAL CANCER  1  0/375 (0.00%)  1/389 (0.26%) 
TESTICULAR CANCER METASTATIC  1  0/375 (0.00%)  1/389 (0.26%) 
Nervous system disorders     
DIZZINESS  1  0/375 (0.00%)  1/389 (0.26%) 
PERIPHERAL NERVE LESION  1  1/375 (0.27%)  0/389 (0.00%) 
PRESYNCOPE  1  1/375 (0.27%)  0/389 (0.00%) 
SYNCOPE  1  1/375 (0.27%)  0/389 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/375 (0.00%)  1/389 (0.26%) 
Psychiatric disorders     
ACUTE PSYCHOSIS  1  1/375 (0.27%)  0/389 (0.00%) 
Renal and urinary disorders     
RENAL FAILURE  1  0/375 (0.00%)  1/389 (0.26%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/375 (0.27%)  0/389 (0.00%) 
LUNG DISORDER  1  0/375 (0.00%)  1/389 (0.26%) 
LUNG INFILTRATION  1  0/375 (0.00%)  1/389 (0.26%) 
PLEURAL EFFUSION  1  1/375 (0.27%)  0/389 (0.00%) 
PULMONARY EMBOLISM  1  0/375 (0.00%)  2/389 (0.51%) 
PULMONARY OEDEMA  1  0/375 (0.00%)  1/389 (0.26%) 
PYREXIA  1  1/375 (0.27%)  0/389 (0.00%) 
RESPIRATORY FAILURE  1  1/375 (0.27%)  1/389 (0.26%) 
Skin and subcutaneous tissue disorders     
URTICARIA * 1  1/375 (0.27%)  0/0 
Vascular disorders     
PHLEBITIS  1  1/375 (0.27%)  0/389 (0.00%) 
SHOCK  1  1/375 (0.27%)  0/389 (0.00%) 
THROMBOSIS  1  1/375 (0.27%)  0/389 (0.00%) 
VENOUS THROMBOSIS LIMB  1  1/375 (0.27%)  0/0 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   87/375 (23.20%)   129/389 (33.16%) 
Blood and lymphatic system disorders     
ANAEMIA  1  0/375 (0.00%)  6/389 (1.54%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/375 (0.00%)  13/389 (3.34%) 
ABDOMINAL PAIN UPPER  1  6/375 (1.60%)  10/389 (2.57%) 
CONSTIPATION  1  10/375 (2.67%)  15/389 (3.86%) 
DIARRHOEA  1  7/375 (1.87%)  0/389 (0.00%) 
NAUSEA  1  11/375 (2.93%)  10/389 (2.57%) 
Infections and infestations     
CYSTITIS  1  0/375 (0.00%)  6/389 (1.54%) 
URINARY TRACT INFECTION  1  7/375 (1.87%)  8/389 (2.06%) 
Metabolism and nutrition disorders     
HYPOKALAEMIA  1  0/375 (0.00%)  7/389 (1.80%) 
Nervous system disorders     
DIZZINESS  1  6/375 (1.60%)  5/389 (1.29%) 
HEADACHE  1  8/375 (2.13%)  11/389 (2.83%) 
Psychiatric disorders     
INSOMNIA  1  0/375 (0.00%)  9/389 (2.31%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  0/375 (0.00%)  8/389 (2.06%) 
Skin and subcutaneous tissue disorders     
PYREXIA  1  17/375 (4.53%)  14/389 (3.60%) 
Vascular disorders     
HYPERTENSION  1  6/375 (1.60%)  7/389 (1.80%) 
PHLEBITIS  1  9/375 (2.40%)  0/389 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca