Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication
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.
Helicobacter Pylori Infection
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Helicobacter pylori infection eradication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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.
|Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology|
|Kayseri, Turkey, 38039|
|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.|