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

NCT03362268 | Completed Phase 2

• 1 other identifier: Livzon-IYI-Ⅱ
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peptic Ulcer Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The rate of hemostasis peptic ulcer hemorrhage patients

  Measure: The hemostasis rate checked by endoscopy within 72 hours

  72 hours

Study Arms (2)

Ilaprazole

EXPERIMENTAL

Drug: Ilaprazole

omeprazole

ACTIVE COMPARATOR

Drug: omeprazole

Interventions

Ilaprazole DRUG

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

Ilaprazole

omeprazole DRUG

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

omeprazole

Eligibility Criteria

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

You may qualify if:

• were 18-65 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 (multiple ulcers was judged by the higher Forrest level).
• 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.
• voluntarily sign informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

ilaprazole; Omeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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 2
• 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: November 28, 2017
• First Posted: December 5, 2017
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 6, 2017

Record last verified: 2017-11