Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02726269
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2016-03-28
Brief Title:
Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico
Sponsor:
Asofarma de México SA de CV
Organization:
Asofarma de México SA de CV
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes pantoprazole 80 mg levofloxacin 500 mg azithromycin 500 mg once daily PLA test vs clarithromycin 500 mg lansoprazole 30 mg amoxicillin 1 g twice daily CLA reference each during 10 days over Helicobacter Pylori HP eradication Both schemes will be tested in treatment-naive patients with biopsy-based diagnosis for HP infection One month after finishing each treatment C13-urea breath testing will be required to verify HP eradication Biopsies will also be taken to identify Clarithromycin-resistance mutations in HP strains by fluorescence in situ hybridization FISH
Detailed Description:
This phase IIIb study is a prospective open-label randomized parallel-group non-inferiority efficacy and safety trial It will be carried out at four outpatient clinics in two cities placed in Mexico Mexico City and the town of Toluca The study was approved by a central Ethics Committee and by COFEPRIS Mexican Federal Commission for Sanitary Risks Protection and will be conducted in accordance with Helsinki Declaration for the protection of human subjects and with Good Clinical Practice guidelines
Two hundred and thirty subjects aged 18 to 65 years with HP infection proven by endoscopic biopsy and treatment-naïve will be included in the study after signing the informed consent They will be randomly allocated into one of two groups Group 1 will receive clarithromycin 500 mg twice daily bid amoxicillin 1 g bid and lansoprazole 30 mg bid Pylopac Medix SA de CV Mexico Group 2 will receive azithromycin 500 mg once daily od Truxa Laboratorios Monte Verde SA Argentina levofloxacin 500 mg od Laboratorios Asofarma de México SA de CV Mexico and pantoprazole 80 mg od Zoltum Laboratorio Monte Verde SA Argentina Both groups will receive the treatment for 10 days Antibiotics will be prescribed after meals whereas the proton-pump inhibitor will be taken in a fasting condition No other medication will be allowed until the end of the treatment
Subjects will be evaluated using the 13C-urea breath test 13C-UBT four weeks after HP eradication treatment Eradication of H pylori will be defined as a negative 13C-UBT No further medication will be allowed during the four weeks preceding the 13C-UBT
Regarding safety assessment blood samples will be collected in a central laboratory following signature of the informed consent and before treatment beginning An additional blood sample will be drawn at the end of treatment of each group for comparison with initial results Patient compliance and treatment-related AEs will be assessed at the end of the treatment except whether the AE is serious in which case it will be reported immediately and appropriate actions will be decided at that time
All biopsies will be reviewed by a central pathologist Endoscopic biopsies will be immediately fixed in 10 buffer formalin embedded in paraffin sectioned 4 mm slice thickness and dehydrated in a series of increasing ethanolxylol concentration Each section will be stained with hematoxylin and eosin HE The diagnosis of gastritis will be established in accordance with the updated Sydney system10 Fluorescent in situ hybridization FISH will be performed in all biopsies Briefly formalin-fixed paraffin-embedded 4-mm tissue sections will be spotted onto slides coated with poly-L-lysine and processed by hexane and ethanol Hybridization will be done using the commercially available BACTfish H pylori combi kit Izinta Trading Co Ltd Hungary The probe for H pylori identification Hpy 1 5CACACCTGACTGACTATCCCG-3 will be labeled with fluorescein isothiocyanate FITC that provides a green signal and the probes that detect the three most prevalent clarithromycin-resistance mutations ClaR1 A2143G 5CGGGGTCTTCCCGTCTt-3 ClaR2 A2144G 5CGGGGCTCTCCGTCTT-3 and ClaR3 A21443C 5-CGGGGTCTTGCCGTCTT-3 will be labeled with red fluorochrome Cy3 Following hybridization for 90 minutes at 46 C sections will be washed with wash buffer twice at 46 C for 15 minutes Air-dried sections will be stained with 4 6 diamino-2-phenylindole DAPI Slides will be evaluated using fluorescence Nikon Eclipse 80i microscope Pictures will be taken with a Nikon DS-Fi1 camera and processed with NIS-Elements 21 software
Continuous variables will be described using means and standard deviation Efficacy analysis will be based on H pylori eradication rate in subjects that finished treatment as per protocol Considering a non-inferiority approach Group 2 will be considered not inferior to Group 1 if the upper limit of the 95 confidence interval CI for the difference in the eradication rate between both groups is lower than the pre-established non-inferiority margin δ 012 Such margin was selected in accordance with previously published trials performed with the reference combination
Chi-square test and Students t-test will be used to compare both groups regarding baseline data eradication rate adverse events and biochemical results for safety analysis P value 005 will be considered significant IBM SPSS 21 will be used to perform the statistical analysis
Two hundred and thirty subjects aged 18 to 65 years with HP infection proven by endoscopic biopsy and treatment-naïve will be included in the study after signing the informed consent They will be randomly allocated into one of two groups Group 1 will receive clarithromycin 500 mg twice daily bid amoxicillin 1 g bid and lansoprazole 30 mg bid Pylopac Medix SA de CV Mexico Group 2 will receive azithromycin 500 mg once daily od Truxa Laboratorios Monte Verde SA Argentina levofloxacin 500 mg od Laboratorios Asofarma de México SA de CV Mexico and pantoprazole 80 mg od Zoltum Laboratorio Monte Verde SA Argentina Both groups will receive the treatment for 10 days Antibiotics will be prescribed after meals whereas the proton-pump inhibitor will be taken in a fasting condition No other medication will be allowed until the end of the treatment
Subjects will be evaluated using the 13C-urea breath test 13C-UBT four weeks after HP eradication treatment Eradication of H pylori will be defined as a negative 13C-UBT No further medication will be allowed during the four weeks preceding the 13C-UBT
Regarding safety assessment blood samples will be collected in a central laboratory following signature of the informed consent and before treatment beginning An additional blood sample will be drawn at the end of treatment of each group for comparison with initial results Patient compliance and treatment-related AEs will be assessed at the end of the treatment except whether the AE is serious in which case it will be reported immediately and appropriate actions will be decided at that time
All biopsies will be reviewed by a central pathologist Endoscopic biopsies will be immediately fixed in 10 buffer formalin embedded in paraffin sectioned 4 mm slice thickness and dehydrated in a series of increasing ethanolxylol concentration Each section will be stained with hematoxylin and eosin HE The diagnosis of gastritis will be established in accordance with the updated Sydney system10 Fluorescent in situ hybridization FISH will be performed in all biopsies Briefly formalin-fixed paraffin-embedded 4-mm tissue sections will be spotted onto slides coated with poly-L-lysine and processed by hexane and ethanol Hybridization will be done using the commercially available BACTfish H pylori combi kit Izinta Trading Co Ltd Hungary The probe for H pylori identification Hpy 1 5CACACCTGACTGACTATCCCG-3 will be labeled with fluorescein isothiocyanate FITC that provides a green signal and the probes that detect the three most prevalent clarithromycin-resistance mutations ClaR1 A2143G 5CGGGGTCTTCCCGTCTt-3 ClaR2 A2144G 5CGGGGCTCTCCGTCTT-3 and ClaR3 A21443C 5-CGGGGTCTTGCCGTCTT-3 will be labeled with red fluorochrome Cy3 Following hybridization for 90 minutes at 46 C sections will be washed with wash buffer twice at 46 C for 15 minutes Air-dried sections will be stained with 4 6 diamino-2-phenylindole DAPI Slides will be evaluated using fluorescence Nikon Eclipse 80i microscope Pictures will be taken with a Nikon DS-Fi1 camera and processed with NIS-Elements 21 software
Continuous variables will be described using means and standard deviation Efficacy analysis will be based on H pylori eradication rate in subjects that finished treatment as per protocol Considering a non-inferiority approach Group 2 will be considered not inferior to Group 1 if the upper limit of the 95 confidence interval CI for the difference in the eradication rate between both groups is lower than the pre-established non-inferiority margin δ 012 Such margin was selected in accordance with previously published trials performed with the reference combination
Chi-square test and Students t-test will be used to compare both groups regarding baseline data eradication rate adverse events and biochemical results for safety analysis P value 005 will be considered significant IBM SPSS 21 will be used to perform the statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None