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

NCT05841394 | Completed Phase 3

• 1 other identifier: LZ1075
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress Ulcer Bleeding

Outcome Measures

Primary Outcomes (4)

• Preventing clinically significant gastrointestinal bleeding

  (1) Bright red blood is observed in gastric tube and not cleared by gavage washing with at least 100mL of standard physiological saline at room temperature for 5 to 10 minutes;

  Day 1 to Day 3

• Preventing clinically significant gastrointestinal bleeding

  (2) During the Day 1 to Day 2 days of the treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, every 2 hours (± 20 minutes) from the time of first observation, and the coffee-like substances were still observed after 8 hours (the occult blood screening reagent remains positive, and the occult blood result is required to be positive);

  Day 1 and Day 2

• Preventing clinically significant gastrointestinal bleeding

  (3) On the Day 3 of the treatment - end of treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, once per hour (± 20 minutes), and the coffee-like substances are still observed after 4 hours (occult blood screening reagent continues to be positive, and occult blood results are required to be positive).

  Day 3

• Preventing clinically significant gastrointestinal bleeding

  (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).

  Day 1 to Day 3

Study Arms (2)

Esomeprazole Sodium

ACTIVE COMPARATOR

40 mg twice daily (q12h)

Drug: Esomeprazole 40mg; Drug: Placebo 2

Ilaprazole Sodium

EXPERIMENTAL

10 mg once daily, 20 mg dosed in the first day.

Drug: Ilaprazole Sodium; Drug: Placebo 1

Interventions

Esomeprazole 40mg DRUG

40 mg i.v. twice daily (q12h)

Esomeprazole Sodium

Ilaprazole Sodium DRUG

10 mg i.v. once daily, 20 mg i.v. in the first day.

Ilaprazole Sodium

Placebo 1 DRUG

Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.

Ilaprazole Sodium

Placebo 2 DRUG

Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.

Esomeprazole Sodium

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (2)

Shanghai Jiaotong University Affiliate Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

The First Affiliated Hopspital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 3, 2023
• Study Start: July 16, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 3, 2023

Record last verified: 2022-08

Locations

CN (2)