Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori

Helicobacter Pylori Eradication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873065
• Other study ID #: LivzonIY-81149R-11-02
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2016
• Last updated: August 16, 2016
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Description:

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.

• Subject who fully understands conditions of clinical trial.

• Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

• Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin

• Subjects who are taking contraindicated medications for experimental and concomitant drug

• Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study

• Pregnant and/or lactating women

• Reproductive aged women not using contraception

• Uncontrolled diabetics

• Uncontrolled hypertension

• Uncontrolled liver dysfunction

• Alcoholics

• Subjects with a history of digestive malignancy within 5 years

• Subjects with a history of gastrectomy or esophagectomy

• Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption

• Subjects participating in a clinical trial before another trial within 30 days

• Inconsistent judged subject by researcher

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Drug:
• Ilaprazole

• Esoprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of Helicobacter pylori as assessed by UBT test		4 weeks	No
Secondary	Frequency of side effects of each treatment		2 months	Yes