CompletedPhase 3

A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Prevention of Stress Ulcer Bleeding

China449 participantsStarted 2021-07-16

Plain-language summary

The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. complex organ surgery at Level 3 or above (surgery duration \> 3 hours);
✓. disease history of gastrointestinal ulcer or hemorrhage;
✓. multiple injuries (score (ISS) ≥ 16);
✓. shock
✓. multiple organ dysfunction syndrome (MODS);
✓. sepsis (as per definition of issued by the Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) in 2016)
✓. acidosis (arterial pH \< 7.3);
✓. coagulation dysfunction (INR \> 1.5, platelets \< 50 \* 109/L or APTT \> 2 times normal value;

What they're measuring

Preventing clinically significant gastrointestinal bleeding

Timeframe: Day 1 to Day 3

Preventing clinically significant gastrointestinal bleeding

Timeframe: Day 1 and Day 2

Preventing clinically significant gastrointestinal bleeding

Timeframe: Day 3

Preventing clinically significant gastrointestinal bleeding

Timeframe: Day 1 to Day 3

Trial details

NCT IDNCT05841394

SponsorLivzon Pharmaceutical Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-28

View on ClinicalTrials.gov More Stress Ulcer Bleeding trials