Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01131026|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Levofloxacin Drug: Amoxicillin Drug: Lansoprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- Helicobacter pylori infection eradication [ Time Frame: 6 weeks ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131026
|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.|