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

Phase 3

Completed

• Conditions: Stress Ulcer Bleeding
• Interventions: Drug: Ilaprazole Sodium; Drug: Esomeprazole 40mg; Drug: Placebo 2; Drug: Placebo 1

• Registration Number: NCT05841394
• Lead Sponsor: Livzon Pharmaceutical Group Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-16
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2022-08
• Study First Submitted: 2023-04-22
• Study First Submitted QC: 2023-04-22
• Last Update Submitted: 2023-04-22
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

• voluntarily signed informed consent form by subjects per se or their guardians.

• 18-74 years of age, female or male;

• required by the ICU treatment, and is intended to be treated over 72 hours.

• intragastrically intubated for at least 72 hours;

• APACHE II scoring within 15 to 25 (containing upper and lower value)

• intubated by mechanical assistance for breath for intended 48 hours without permission of assistance withdrawal. (Combing clinical observation, patients judged cannot breathing without artificial assistance within 48 hours should meet the any of criteria as following: 1) PEEP > 5; 2) FiO2 > 0.4; 3) Pressure of assisting breathing machine > 13 cmH2O; 4) body temperature over 38℃; 5) CRP ≥ 100 mg/L.

• in addition to mechanical ventilation, at least one major factor that may lead to irritable ulcer bleeding occurred as following within 48 hours prior to random group-assignment.

  1. complex organ surgery at Level 3 or above (surgery duration > 3 hours);
  2. disease history of gastrointestinal ulcer or hemorrhage;
  3. multiple injuries (score (ISS) ≥ 16);
  4. shock
  5. multiple organ dysfunction syndrome (MODS);
  6. sepsis (as per definition of issued by the Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) in 2016)
  7. acidosis (arterial pH < 7.3);
  8. coagulation dysfunction (INR > 1.5, platelets < 50 * 109/L or APTT > 2 times normal value;
  9. coma (GCS ≤ 10);
  10. receiving high dose corticosteroids (over 250 mg/d hydrocortisone or other equivalent dose corticosteroids);
  11. 30%-70% body surface burn;

Exclusion Criteria

• a history of gastric or esophageal surgery, intestinal obstruction, or hospitalization in the ICU after esophageal, gastric, or duodenal surgery in the past 3 months;
• lesions of the upper digestive tract (e.g., duodenal ulcer, gastric ulcer, acute gastric mucosa lesions, esophageal varices, malignant tumors, etc.) that are known to be likely to bleed, and other evidences indicating gastrointestinal bleeding occurs (esophageal and gastric varices bleeding, duodenal ulcer bleeding);
• hemoglobin < 60g/L (6.0g/dl);
• significant factor indicating bleed occurs during swallowing (such as oral and maxillofacial injuries, hemoptysis, etc.);
• renal failure;
• cardiopulmonary resuscitation conducted during hospitalization period;
• serious liver disease, defined as Child-Pugh C-grade;
• contraindicated for gastric intubation (such as esophageal stenosis);
• pregnancy or pregnancy test showing positive;
• documented or supposed to be hypersensitive to PPIs (Ilaprazole, Esomeprazole, Omeprazole, Lansoprazole, Dextran lansoprazole, Rabeprazole or Pantoprazole);
• participated in other clinical studies within 30 days prior to random assignment;
• use any PPI or treated by H2RA within 12 hours prior to random assignment;
• co-administering or unavoidable using drugs that may interact with Ilaprazole Sodium or Esomeprazole Sodium: e.g., Warfarin (including other vitamin K antagonists), Cisapride, Phenytoin, Atazanavir, Nefenavir, Ritonavir, Saquinavir, Digoxin, Tacrolimus, Methotrexate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ilaprazole Sodium	Ilaprazole Sodium	10 mg once daily, 20 mg dosed in the first day.
Esomeprazole Sodium	Esomeprazole 40mg	40 mg twice daily (q12h)
Esomeprazole Sodium	Placebo 2	40 mg twice daily (q12h)
Ilaprazole Sodium	Placebo 1	10 mg once daily, 20 mg dosed in the first day.

Primary Outcome Measures

Name	Time	Method
Preventing clinically significant gastrointestinal bleeding	Day 1 to Day 3	(4) Hematemesis or bloody stools originating from the upper gastrointestinal tract (as determined by the researchers, such as tarry stools and positive gastric occult blood).

Trial Locations

Locations (2)

Shanghai Jiaotong University Affiliate Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hopspital of Xinjiang Medical University; 🇨🇳 Urumchi, Xinjiang, China