High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

Bleeding Peptic Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757275
• Other study ID #: D961DC00007
• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures.

• Female or male aged =18 years and =70 years.

• Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.

• One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.

• Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Exclusion Criteria:

• Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.

• Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.

• Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.

• Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.

• Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.

Study Design

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

Related Conditions & MeSH terms

• Bleeding Peptic Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

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

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Chongqing
China	Research Site	Guangzhou
China	Research Site	Ha'er bing
China	Research Site	Hangzhou
China	Research Site	Ji Nan
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Wuhan
China	Research Site	Xian

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

External Links

•   China_PUB_Study_D961DC00007_Clinical_Study_Protocol_GEL_Redacted_(approved)