Stress Ulcer BleedingPhase 3NCT05841394
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
A Phase 3 study testing Esomeprazole 40mg and Ilaprazole Sodium in people with Stress Ulcer Bleeding, run by Livzon Pharmaceutical Group Inc. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Stress Ulcer Bleeding
- What is being tested?
- Esomeprazole 40mg and Ilaprazole Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jul 2021to 28 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Jiaotong University Affiliate Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
The First Affiliated Hopspital of Xinjiang Medical University
Ürümqi, Xinjiang
About this study
Official title: 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.
- Conditions
- Stress Ulcer Bleeding
- Being tested
- Esomeprazole 40mg, Ilaprazole Sodium, Placebo 1, Placebo 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mgDrug
40 mg i.v. twice daily (q12h)
Ilaprazole SodiumDrug
10 mg i.v. once daily, 20 mg i.v. in the first day.
Placebo 1Drug
Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.
Placebo 2Drug
Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole Sodium | Active comparator | 40 mg twice daily (q12h) Receives: Drug: Esomeprazole 40mg; Drug: Placebo 2 |
| Ilaprazole Sodium | Experimental | 10 mg once daily, 20 mg dosed in the first day. Receives: Drug: Ilaprazole Sodium; Drug: Placebo 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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);
Measured: 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).
Measured: 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).
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start16 Jul 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Ulcer BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841394
- Sponsor's protocol ID
- LZ1075
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.)
- ClinicalTrials.gov ID
- NCT05841394
- Acronym / sponsor ID
- LZ1075
- Conditions
- Stress Ulcer Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole Sodium | Active comparator | Drug: Esomeprazole 40mg, Drug: Placebo 240 mg twice daily (q12h) |
| Ilaprazole Sodium | Experimental | Drug: Ilaprazole Sodium, Drug: Placebo 110 mg once daily, 20 mg dosed in the first day. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole 40mg40 mg i.v. twice daily (q12h) | Drug | Esomeprazole Sodium |
| Ilaprazole Sodium10 mg i.v. once daily, 20 mg i.v. in the first day. | Drug | Ilaprazole Sodium |
| Placebo 1Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h. | Drug | Ilaprazole Sodium |
| Placebo 2Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day. | Drug | Esomeprazole Sodium |
Primary outcome
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;
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);
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole 40mg and Ilaprazole Sodium in people with Stress Ulcer Bleeding, run by Livzon Pharmaceutical Group Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preventing clinically significant gastrointestinal bleeding (time frame: Day 1 to Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.