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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01757275
Other study ID # D961DC00007
Secondary ID
Status Completed
Phase Phase 3
First received December 21, 2012
Last updated February 9, 2016
Start date February 2013
Est. completion date December 2014

Study information

Verified date February 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Description:

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


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Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Esomeprazole Na
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
Cimetidine
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
Esomeprazole Mg
40 mg tablet once daily for 27 days

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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
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.
72 hours No
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.
7 days No
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.
30 days No
Secondary Number of Patients With Endoscopic Re-treatment Within 72 Hours 72 hours No
Secondary Number of Patients With Endoscopic Re-treatment Within 30 Days 30 days No
Secondary Number of Patients With Surgery Due to Rebleeding Within 72 Hours within 72 hours No
Secondary Number of Patients With Surgery Due to Rebleeding Within 30 Days within 30 days No
Secondary Number of Blood Units Transfused Within 72 Hours within 72 hours No
Secondary Number of Blood Units Transfused Within 30 Days within 30 days No
See also
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Not yet recruiting NCT04170270 - Oral Omeprazole in Bleeding Peptic Ulcer Early Phase 1
Not yet recruiting NCT06196710 - The Use of OTSC in LBGDU to Standard Endoscopic Hemostatic Methods N/A
Completed NCT01675856 - Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB) N/A
Recruiting NCT00164827 - Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy Phase 3
Completed NCT04366583 - Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers Phase 4
Completed NCT02245802 - Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers N/A
Recruiting NCT01845168 - Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice N/A