IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients

December 4, 2017 updated by: Livzon Pharmaceutical Group Inc.

Efficacy and Safety of Intravenous IIaprazole for Peptic Ulcer Bleeding: A Randomized, Double-Blind, Omeprazole-Controlled, Multicenter, and Phase 2 Trail in China

The purpose of this study is to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically diagnosed peptic ulcer bleeding were enrolled in a randomized, 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 and be seen at day 3, 4, 7, 14 and 30. The primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end points include effective rate of hemostasis, mean volume of blood transfusion, the length of stay and re-bleeding rate, etc.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with endoscopically diagnosed gastric and duodenal ulcer bleeding were randomly assigned into two groups, ilaprazole and omeprazole. 120 patients were administrated 10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to oral administration. Other 60 patients were administrated 40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min. Since 4th day, those patients were changed to oral administration. The efficacy of ilaprazole and omeprazole was evaluated by the primary endpoint including the hemostasis rate (hemostatic groups with endoscopy check ) and re-bleeding rate (bleeding groups with endoscopy check) within 72 hours and secondary end points including effective rate of hemostasis, average blood transfusion, the need to switch to other treatments (endoscopic treatment or surgery, etc.), hospital stay and re-bleeding rate at day 7, 14 and 30. Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes,including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.This phase Ⅱ clinical trial was designed to compare the efficacy and safety of ilaprazole and omeprazole in the treatment and prevention of peptic ulcer bleeding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. were 18-65 years of age, male or female.
  2. had symptoms of hematemesis, hematochezia, melena within 24 hours and clinically diagnosed as peptic ulcer bleeding.
  3. had endoscopically diagnosed gastric or duodenal ulcer bleeding (multiple ulcers was judged by the higher Forrest level).
  4. were patients of Forrest Ⅰa-Ⅱb level and had successful endoscopic surgery to stop bleeding (bleeding was cured and the blood vessels were flat or became into the lumen). Ⅱc-Ⅲ grade patients did not receive endoscopic hemostasis.
  5. voluntarily sign informed consent.

Exclusion Criteria:

  1. had hemorrhagic shock (systolic blood pressure<90mmHg) or require surgery.
  2. were non-ulcer bleeding and gastric ulcer biopsy proved malignant.
  3. had gastrectomy and gastrointestinal anastomosis.
  4. were suffering from serious heart, liver, brain, lung, kidney and other serious diseases.
  5. 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).
  6. had hypersensitivity or idiosyncratic reaction to ilaprazole, omeprazole, esomeprazole or any other benzimidazole.
  7. had positive result of urine pregnancy test.
  8. used the same kind of drugs within 48 hours before entering the group.
  9. 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.
  10. participated in a clinical trial with an investigational drug or device within the past three months.
  11. had alcoholic intemperance, drug addiction or other factors that researchers think it unfit for drug clinical trials.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Ilaprazole
Drug: Ilaprazole
10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day
ACTIVE_COMPARATOR: omeprazole
Drug: omeprazole
40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min,Since 4th day, those patients were changed to take oral omeprazole tablets 20mg each day till 30th day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of hemostasis peptic ulcer hemorrhage patients
Time Frame: 72 hours
Measure: The hemostasis rate checked by endoscopy within 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Livzon Pharmaceutical Group Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Livzon-IYI-Ⅱ

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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