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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deva Holding A.S.
• Collaborators: TC Erciyes University; TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.
• Treatments: Amoxicillin; Dexlansoprazole; Lansoprazole; Levofloxacin; Ofloxacin

Criteria

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.