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

NCT01131026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-08-09

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Levofloxacin

tablet, 500 mg, once a day for ten days

DRUG

Amoxicillin

tablet, 1000 mg, once a day for ten days

DRUG

Lansoprazole

capsule, 30 mg, twice a day for ten days

Sponsors & Collaborators

  • TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.

    collaborator OTHER

  • TC Erciyes University

    collaborator OTHER

  • Deva Holding A.S.

    lead INDUSTRY

Principal Investigators

  • Mehmet Yucesoy, MD · Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology

  • Recep S Alpan, MD, PhD, MSc · TNC Pharmaceuticals Research, Development and Consultancy Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01131026 on ClinicalTrials.gov