Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.
|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: NCT02726269|
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Gastritis||Drug: CLA (Clarithro+Lanso+Amoxi) Drug: PLA (Panto+Levoflox+Azithro)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Helicobacter Pylori Eradication in Mexico With a Levofloxacin-containing Scheme Versus Clarithromycin-based Triple Therapy: a Randomized, Open-label, Non-inferiority, Phase 3b Trial.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: CLA (Clarithro+Lanso+Amoxi)
Clarithromycin 500 mg bid, Lansoprazole 30 mg bid and Amoxicillin 500 bid, tablets of oral administration, during 10 days.
Drug: CLA (Clarithro+Lanso+Amoxi)
Tablets of oral administration administered to subjects randomized to this group twice daily for 10 days.
Other Name: Pylopac®, Medix, Mexico
Experimental: PLA (Panto+Levoflox+Azithro)
Pantoprazole 80 mg od, Levofloxacin 500 mg od and Azithromycin 500 mg od, tablets of oral administration, during 10 days.
Drug: PLA (Panto+Levoflox+Azithro)
Tablets of oral administration to subjects randomized to this group once daily for 10 days.
Other Name: Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex
- HP eradication rate calculated from negative 13C-urea breath tests. [ Time Frame: Four weeks after the end of the allocated treatment. ]
- Determine the frequency of Clarithromycin-resistance mutations by fluorescence in situ hybridization (FISH). [ Time Frame: Within a month after taking gastric endoscopy biopsy to confirm the diagnosis of HP infection. ]
- Compare the proportion of Clarithromycin-resistance mutations determined by FISH with the HP eradication rate calculated. [ Time Frame: A week after both proportions are calculated. ]
- Percentage and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) in each group (PLA vs CLA). [ Time Frame: Up to a month after the end of both treatments. ]
- Proportion of treatments prematurely suspended due to AEs or SAEs in each group (PLA vs CLA). [ Time Frame: Within ten days after each treatment is randomly allocated. ]
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): NCT02726269
|Principal Investigator:||Alma L Ladrón de Guevara, MD|