Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Deva

Status and phase

Completed

Phase 3

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Amoxicillin

Drug: Levofloxacin

Drug: Lansoprazole

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01131026

DV-09-0015

Details and patient eligibility

About

Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.

Full description

The primary end point in this study is appointed to be "Helicobacter pylori infection eradication with TRIOL treatment" and the secondary end point as "safety". The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Consenting to an endoscopy
Signing the informed consent form
Not receiving Helicobacter pylori eradication treatment before
Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining
Being older than 18 years of age

Exclusion criteria

Being younger than 18 years of age
Receiving H. pylori eradication treatment previously
Having gastrectomy or vagotomy in medical history
Having gastric malignancy, including adenocarcinoma and lymphoma
Having other severe malignant disease
Previously having allergic reaction to antibiotics (amoxicillin, levofloxacin) and proton pump inhibitors (lansoprazole)
Using prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the last 4 weeks
Having active upper GI bleeding in the last week
Being pregnant or lactating
Taking long term high dosages of aspirin, corticosteroid and other NSAIDs in the last 4 weeks
Taking any antibiotics or proton pump inhibitors other than the study medication during the study period
Taking antacids and/or H2-blockers during the study period
Taking bismuth compounds within four weeks prior to and during the study period
Having dysphasia or vomiting as major symptoms
Having psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study
Having severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
Having known uncontrolled hypertension
Being immunocompromised
Showing clinically significant abnormal vital signs
Having clinically significant abnormal ECG findings
Presenting clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety
Being exposed to any investigational drug within 30 days prior to screening
Having known hypersensitivity to or contraindication against fluoroquinolones.
Having current diagnosis or known history of substance abuse.