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NCT Number: NCT01757275

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

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

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Key information

Conditions

Bleeding Peptic Ulcer Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Hemorrhage

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole Na

Drug

Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous

Other names: Nexium

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

Other names: Nexium

Primary outcomes

  1. Rate of Clinically Significant Rebleeding Within 72 Hours

    Time frame: 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Number of Patients With Endoscopic Re-treatment Within 72 Hours

    Time frame: 72 hours

  4. Number of Patients With Endoscopic Re-treatment Within 30 Days

    Time frame: 30 days

  5. Number of Patients With Surgery Due to Rebleeding Within 72 Hours

    Time frame: within 72 hours

  6. Number of Patients With Surgery Due to Rebleeding Within 30 Days

    Time frame: within 30 days

  7. Number of Blood Units Transfused Within 72 Hours

    Time frame: within 72 hours

  8. Number of Blood Units Transfused Within 30 Days

    Time frame: within 30 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2012
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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