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Completed

NCT Number: NCT02157376

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Baotou, China

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About this study

Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Critically ill patients
  • Requirement for mechanical ventilation
  • At least one major risk factor for stress ulcer related bleeding

Exclusion criteria

  • History of gastric or oesophageal surgery
  • Evidence of active GI bleeding
  • Advanced renal disease
  • Treatment with any Proton Pump Inhibitors

Treatment and study plan

Esomeprazole

Drug

iv esomeprazole 30 min intermittent infusions given for maximum 14 days

Other names: Nexium

Cimetidine

Drug

iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Other names: Tagamet

Primary outcomes

  1. The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase

    Time frame: 1-14 days

    Criteria for a clinically significant upper GI bleeding as:

    • Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or,
    • Persistent gastroccult- positive coffee ground material

    During IMP treatment Day 1-2:

    Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline.

    During IMP treatment Day 3-14:

    Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.

Secondary outcomes

  1. Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase

    Time frame: 1-14 days

    Criteria for a significant upper GI bleeding as described in primary outcome measure or,

    Criteria for a non-significant upper GI bleeding as:

    • Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or,
    • Persistent gastroccult- positive coffee ground material

    During IMP treatment Day 1-2:

    Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline.

    During IMP treatment Day 3-14:

    Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or,

    • Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study

Acronym: SUP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2014
Registry last updated
Mar 10, 2017

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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