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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary: 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
Sponsor: AstraZeneca

Current Primary Outcome: Rate of Clinically Significant Rebleeding Within 72 Hours [ Time Frame: 72 hours ]

Original Primary Outcome: The rate of clinically significant rebleeding of continuous i.v. infusion [ Time Frame: During 72 hours infusion phase ]

Current Secondary Outcome:

• Rate of Clinically Significant Rebleeding During 7 Days [ Time Frame: 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.

• Rate of Clinically Significant Rebleeding During 30 Days [ Time Frame: 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.

• Number of Patients With Endoscopic Re-treatment Within 72 Hours [ Time Frame: 72 hours ]
• Number of Patients With Endoscopic Re-treatment Within 30 Days [ Time Frame: 30 days ]
• Number of Patients With Surgery Due to Rebleeding Within 72 Hours [ Time Frame: within 72 hours ]
• Number of Patients With Surgery Due to Rebleeding Within 30 Days [ Time Frame: within 30 days ]
• Number of Blood Units Transfused Within 72 Hours [ Time Frame: within 72 hours ]
• Number of Blood Units Transfused Within 30 Days [ Time Frame: within 30 days ]

Original Secondary Outcome:

• The rate of clinically significant rebleeding [ Time Frame: Within 7 days and 30 days ]
• The rate of patients had endoscopic re-treatment due to rebleeding [ Time Frame: Within 72 hours and 30 days ]
• The rate of patients who had surgery due to rebleeding [ Time Frame: Within 72 hours and 30 days ]
• The number of blood units transfused [ Time Frame: Within 72 hours and 30 days ]
• The number of patients with AE during the continuous I.v. infusion [ Time Frame: Within 72 hours ]
• The number of patients with AE of open oral treatment with esomeprazole Mg 40 mg [ Time Frame: Day 4 to Day 30 ]
• Mean values of S-creatinine, S-ALP, S-AST, S-ALT, B-Bil, Hb, WBCand B-platelets [ Time Frame: At baseline, at 72 hours and at Day 30 ]

Information By: AstraZeneca

Dates:
Date Received: December 21, 2012
Date Started: February 2013
Date Completion:
Last Updated: February 9, 2016
Last Verified: February 2016