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OpenTrials
Completed

NCT Number: NCT00251979

A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Braunau/Inn, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signs of a bleeding in the stomach
  • One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion criteria

  • Malignancy or other advanced disease.
  • Major cardiovascular event.
  • Severe hepatic disease

Treatment and study plan

Esomeprazole

Drug

Primary outcomes

  1. Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo

    Time frame: Within 72 hours

Secondary outcomes

  1. Clinically Significant Rebleeding Within 7 Days

    Time frame: Within 7 days

  2. Clinically Significant Rebleeding Within 30 Days

    Time frame: Within 30 days

  3. Death Within 72 Hours

    Time frame: Within 72 hours

  4. Death Within 30 Days

    Time frame: Within 30 days

  5. Death Related to Rebleeding Within 30 Days as Judged by the EpC

    Time frame: Within 30 days

  6. Requirement for Surgery Within 72 Hours

    Time frame: Within 72 hours

  7. Requirement for Surgery Within 30 Days

    Time frame: Within 30 days

  8. Requirement for Endoscopic Re-treatment Within 72 Hours

    Time frame: Within 72 hours

  9. Requirement for Endoscopic Re-treatment Within 30 Days

    Time frame: Within 30 days

  10. Number of Blood Units Transfused Within 72 Hours

    Time frame: Within 72 hours

  11. Number of Blood Units Transfused Within 30 Days

    Time frame: within 30 days

  12. Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period

    Time frame: Within 30 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 11, 2005
Registry last updated
Jun 17, 2011

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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