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

A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Levofloxacin; Drug: Amoxicillin; Drug: Lansoprazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori infection eradication	After 6 weeks from the end of the TRIOL treatment, demonstrating the ratio of patients who do not develop Helicobacter pylori infection by rapid urease test and Giemsa staining.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	During the study all patients will be examined at the determined timepoints in the protocol in regard to any type of clinical adverse event. These examinations involve clinical and laboratory examinations of which the results will be recorded in the final study report and discussed with respect to the current literature.	6 weeks

Collaborators and Investigators

• Sponsor: Deva Holding A.S.
• Collaborators: TC Erciyes University; TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.
• Investigators: Principal Investigator: Mehmet Yucesoy, MD, Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology; Study Director: Recep S Alpan, MD, PhD, MSc, TNC Pharmaceuticals Research, Development and Consultancy Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Estimate): August 9, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: safety; Helicobacter pylori; efficacy; triple therapy; amoxicillin; lansoprazole; levofloxacin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Dexlansoprazole; Lansoprazole; Amoxicillin; Levofloxacin; Ofloxacin
• Other Study ID Numbers: DV-09-0015