Peptic Ulcer HemorrhagePhase 3NCT03362281
Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
A Phase 3 study testing Ilaprazole, Omeprazole and Ilaprazole tablet in people with Peptic Ulcer Hemorrhage, run by Livzon Pharmaceutical Group Inc..
Trial summary
The purpose of this phase study is to confirm the efficacy and safety by compare ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified randomized, non-inferiority test, double-blind… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Ilaprazole, Omeprazole and Ilaprazole tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were 18-70 years of age, male or female.
- had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding.
- had endoscopically diagnosed gastric or duodenal ulcer bleeding and 3mm ≤ ulcer diameter ≤ 15mm.
- underwent local hemostasis according to "Acute non-variceal upper gastrointestinal bleeding guidelines (2009, Hangzhou)" Forrest grading; multiple ulcers was judged by the higher level.
- voluntarily sign informed consent
Who cannot join
- had hemorrhagic shock ( systolic blood pressure<90mmHg) or require surgery.
- were non-ulcer bleeding and gastric ulcer biopsy proved malignant.
- had gastrectomy and gastrointestinal anastomosis.
- were suffering from serious heart, liver, brain, lung, kidney and other serious diseases.
- had coagulation disorders (laboratory tests showed that platelets <80 × 109 / L, PT abnormal and exceed the normal control for 3 seconds, APTT than the normal control for 10 seconds).
- had hypersensitivity or idiosyncratic reaction to ilaprazole, omeprazole, esomeprazole or any other benzimidazole.
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- had positive result of urine pregnancy test.
- used the same kind of drugs within 48 hours before entering the group.
- need to continue the combination of the following drugs that have an effect on treatment during the study: NSAIDs, corticosteroids, heparin, warfarin and vitamin K, platelet antagonists or other hemostatic agents.
- participated in a clinical trial with an investigational drug or device within the past three months.
- had alcoholic intemperance, drug addiction or other factors that researchers think it unfit for drug clinical trials.
About this study
Official title: Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 3 Trail in China
The purpose of this phase study is to confirm the efficacy and safety by compare ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified randomized, non-inferiority test, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, ilaprazole and omeprazole, to be treated for up to 30 days. The primary endpoint was the hemostasis rate at the end of 72 hours. Secondary end points include ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion and rebleeding rate, etc.
Read the detailed description
Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 360 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Other 180 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion for 30min. Since 4th day, both group taken oral ilaprazole tablets 10mg each day till 30th day; And the Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpointthe-hemostasis rate at the end of 72 hours in the total population, high-risk groups and low-risk groups and secondary end points including ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), the disappearance time of ulcer pain and rebleeding rate. This phase Ⅲ clinical trial was designed to confirm the efficacy and safety of ilaprazole in the treatment of peptic ulcer bleeding and to pride a basis for registration.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Ilaprazole, Omeprazole, Ilaprazole tablet, amoxicillin and clarithromycin
- Keywords
- Peptic ulcer hemorrhage, Proton Pump Inhibitor
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.
OmeprazoleDrug
40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min.
Ilaprazole tabletDrug
Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day
amoxicillin and clarithromycinDrug
The Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole | Experimental | Not described Receives: Drug: Ilaprazole; Drug: Ilaprazole tablet; Drug: amoxicillin and clarithromycin |
| omeprazole | Active comparator | Not described Receives: Drug: Omeprazole; Drug: Ilaprazole tablet; Drug: amoxicillin and clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of hemostasis
the hemostasis rate checked by endoscopy within 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies 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
- 540 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
- NCT03362281
- Sponsor's protocol ID
- Livzon-IYI-Ⅲ
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 6 Dec 2017
- 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 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 3 Trail in China
- ClinicalTrials.gov ID
- NCT03362281
- Acronym / sponsor ID
- Livzon-IYI-Ⅲ
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic ulcer hemorrhage, Proton Pump Inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Dec 2017 (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 phase study is to confirm the efficacy and safety by compare ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified randomized, non-inferiority test, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, ilaprazole and omeprazole, to be treated for up to 30 days. The primary endpoint was the hemostasis rate at the end of 72 hours. Secondary end points include ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion and rebleeding rate, etc.
Detailed description
Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 360 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Other 180 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion for 30min. Since 4th day, both group taken oral ilaprazole tablets 10mg each day till 30th day; And the Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpointthe-hemostasis rate at the end of 72 hours in the total population, high-risk groups and low-risk groups and secondary end points including ulcer staging changes within 72 hours, effective rate of hemostasis, hemostasis duration, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), the disappearance time of ulcer pain and rebleeding rate. This phase Ⅲ clinical trial was designed to confirm the efficacy and safety of ilaprazole in the treatment of peptic ulcer bleeding and to pride a basis for registration.
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 |
|---|---|---|
| Ilaprazole | Experimental | Drug: Ilaprazole, Drug: Ilaprazole tablet, Drug: amoxicillin and clarithromycin |
| omeprazole | Active comparator | Drug: Omeprazole, Drug: Ilaprazole tablet, Drug: amoxicillin and clarithromycin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- were 18-70 years of age, male or female.
- had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding.
- had endoscopically diagnosed gastric or duodenal ulcer bleeding and 3mm ≤ ulcer diameter ≤ 15mm.
- underwent local hemostasis according to "Acute non-variceal upper gastrointestinal bleeding guidelines (2009, Hangzhou)" Forrest grading; multiple ulcers was judged by the higher level.
- voluntarily sign informed consent
Key exclusion criteria (11 listed)
- had hemorrhagic shock ( systolic blood pressure<90mmHg) or require surgery.
- were non-ulcer bleeding and gastric ulcer biopsy proved malignant.
- had gastrectomy and gastrointestinal anastomosis.
- were suffering from serious heart, liver, brain, lung, kidney and other serious diseases.
- had coagulation disorders (laboratory tests showed that platelets <80 × 109 / L, PT abnormal and exceed the normal control for 3 seconds, APTT than the normal control for 10 seconds).
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 |
|---|---|---|
| Ilaprazole10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. | Drug | Ilaprazole |
| Omeprazole40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min. | Drug | omeprazole |
| Ilaprazole tabletSince 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day | Drug | Ilaprazole, omeprazole |
| amoxicillin and clarithromycinThe Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks | Drug | Ilaprazole, omeprazole |
Primary outcome
the rate of hemostasis
Time frame: 72 hours
the hemostasis rate checked by endoscopy within 72 hours
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 6 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ilaprazole, Omeprazole and Ilaprazole tablet in people with Peptic Ulcer Hemorrhage, run by Livzon Pharmaceutical Group Inc..
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 5 inclusion and 11 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
the rate of hemostasis (time frame: 72 hours). 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 6 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.