- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05841394
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
April 22, 2023 updated by: Livzon Pharmaceutical Group Inc.
A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Treatment of Prevention of Stress Ulcer Bleeding (Ilaprazole i.v. vs Esomeprazole, i.v.)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Shanghai Jiaotong University Affiliate Ruijin Hospital
-
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Xinjiang
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Urumchi, Xinjiang, China
- The First Affiliated Hopspital of Xinjiang Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
- 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;
- coma (GCS ≤ 10);
- receiving high dose corticosteroids (over 250 mg/d hydrocortisone or other equivalent dose corticosteroids);
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Esomeprazole Sodium
40 mg twice daily (q12h)
|
40 mg i.v. twice daily (q12h)
Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.
|
Experimental: Ilaprazole Sodium
10 mg once daily, 20 mg dosed in the first day.
|
10 mg i.v.
once daily, 20 mg i.v. in the first day.
Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventing clinically significant gastrointestinal bleeding
Time Frame: Day 1 to Day 3
|
(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
Time Frame: Day 1 and Day 2
|
(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
Time Frame: Day 3
|
(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
Time Frame: 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).
|
Day 1 to Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2021
Primary Completion (Actual)
April 28, 2022
Study Completion (Actual)
April 28, 2022
Study Registration Dates
First Submitted
April 22, 2023
First Submitted That Met QC Criteria
April 22, 2023
First Posted (Actual)
May 3, 2023
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 22, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LZ1075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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