Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole | Experimental |
| |
| Cimetidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole Na | Drug | Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinically Significant Rebleeding Within 72 Hours | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinically Significant Rebleeding During 7 Days | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tore Lind, MD | AstraZeneca Molndal, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26581750 | Derived | Bai Y, Chen DF, Wang RQ, Chen YX, Shi RH, Tian DA, Chen H, Eklund S, Li ZS; Chinese Peptic Ulcer Bleeding Research Group. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients. Adv Ther. 2015 Nov;32(11):1160-76. doi: 10.1007/s12325-015-0265-6. Epub 2015 Nov 18. |
| Label | URL |
|---|---|
| China\_PUB\_Study\_D961DC00007\_Clinical\_Study\_Protocol\_GEL\_Redacted\_(approved) | View source |
Not provided
17 patients were not assigned to treatment, 15 patients did not fulfil the eligibility criteria, 1 was due to patient decision, and 1 patient due to "other" (not enough experimental drug).
Overall, 239 patients were enrolled from 19 centres in China. The first patient entered the study on 26 February 2013 and the last patient completed the study on 30 December 2014.
Of the 239 patients enrolled into the study, 222 (92.9%) patients were randomised to treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole | Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days |
| FG001 | Cimetidine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Cimetidine | Drug | Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours |
|
| Esomeprazole Mg | Drug | 40 mg tablet once daily for 27 days |
|
|
| 7 days |
| Rate of Clinically Significant Rebleeding During 30 Days | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. | 30 days |
| Number of Patients With Endoscopic Re-treatment Within 72 Hours | 72 hours |
| Number of Patients With Endoscopic Re-treatment Within 30 Days | 30 days |
| Number of Patients With Surgery Due to Rebleeding Within 72 Hours | within 72 hours |
| Number of Patients With Surgery Due to Rebleeding Within 30 Days | within 30 days |
| Number of Blood Units Transfused Within 72 Hours | within 72 hours |
| Number of Blood Units Transfused Within 30 Days | within 30 days |
| Changsha |
| China |
| Research Site | Chongqing | China |
| Research Site | Guangzhou | China |
| Research Site | Ha'er Bing | China |
| Research Site | Hangzhou | China |
| Research Site | Jinan | China |
| Research Site | Nanchang | China |
| Research Site | Nanjing | China |
| Research Site | Shanghai | China |
| Research Site | Wuhan | China |
| Research Site | Xi'an | China |
Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
| COMPLETED |
|
| NOT COMPLETED |
|
|
Among 222 randomised patients, 215 patients received iv treatment: 108 patients in the esomeprazole treatment group and 107 patients in the cimetidine treatment group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole | Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days |
| BG001 | Cimetidine | Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Number of patients with one bleeding ulcer | Number | participants |
| ||||||||||||||||
| Forrest class | Forrest classification of PUB (Forrest et al 1974): Ia = arterial bleeding; Ib = oozing bleeding; IIa = non-bleeding visible vessel; IIb = adherent clot. | Number | participants |
| |||||||||||||||
| Bleeding ulcer size | Mean | Standard Deviation | mm |
| |||||||||||||||
| Ulcer location | Number | participants |
| ||||||||||||||||
| Number of patients with ulcers of different sizes | Number | participants |
| ||||||||||||||||
| Number of patients with single and multiple ulcers | Number | participants |
|
| 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 | Rate of Clinically Significant Rebleeding Within 72 Hours | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. | Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS. | Posted | Number | participants | 72 hours |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Clinically Significant Rebleeding During 7 Days | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. | FAS | Posted | Number | participants | 7 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Clinically Significant Rebleeding During 30 Days | Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator. | FAS | Posted | Number | participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Endoscopic Re-treatment Within 72 Hours | FAS | Posted | Number | participants | 72 hours |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Endoscopic Re-treatment Within 30 Days | FAS | Posted | Number | participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Surgery Due to Rebleeding Within 72 Hours | FAS | Posted | Number | participants | within 72 hours |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Surgery Due to Rebleeding Within 30 Days | FAS | Posted | Number | participants | within 30 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Blood Units Transfused Within 72 Hours | FAS | Posted | Number | blood units | within 72 hours |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Blood Units Transfused Within 30 Days | FAS | Posted | Number | blood units | within 30 days |
|
|
AEs will be collected from the time of the first administration of IP until the end of study, up to 35 days. SAEs will be collected from signed inform consent until the end of the study, up to 36 days.
Not provided
Not provided
| 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 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days | 5 | 110 | 22 | 110 | ||
| EG001 | Cimetidine | Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days | 5 | 105 | 20 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Persecutory delusion | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Persecutory delusion | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haematospermia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
No hypothesis testing was performed in this study and, as such, no formal statistical comparisons were made. Two patients who were initially randomised to receive cimetidine treatment actually received esomeprazole treatment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huifang Chen | AstraZeneca | +86 21 60301335 | ariel.chen@astrazeneca.com |
| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D002927 | Cimetidine |
| 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 |
| D006146 | Guanidines |
| D000578 | Amidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
Not provided
Not provided
| >65 years |
|
| Male |
|
| Ib |
|
| IIa |
|
| IIb |
|
| Duodenum |
|
| Stomach and Duodenum |
|
| >2 cm |
|
| Multiple |
|
|
|
|
|
|
|
|
|
|
|