Helicobacter Pylori Eradication Antibiotic Clinical Trial
Official title:
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
| NCT number | NCT02835560 |
| Other study ID # | Livzon-IY-81149R |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | July 9, 2016 |
| Last updated | July 15, 2016 |
| Start date | June 2013 |
| Verified date | June 2012 |
| Source | Livzon Pharmaceutical Group Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple
regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin
500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment
of H.pylori.
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 14 days, participants treated as Esoprazole based
bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth
Potassium Citrate 220mg, 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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | July 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, Amoxicillin and Levofloxacin. - Subjects who are taking contraindicated medications for experimental and concomitant drug. - Patients with abnormal levels in the laboratory tests. - Total Bilirubin, Creatinine> 1.5 times upper limit of normal. - AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Livzon Pharmaceutical Group Inc. | Fifth Affiliated Hospital, Sun Yat-Sen University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Eradication rate of Helicobacter pylori as assessed by UBT test | up to 2 months | No |