]>
IRCT20211019052812N1 IRCT 2021-11-06 Ahvaz University of Medical Sciences Comparison the amoxicillin and pantoprazole regimen with quadruple regimen for Helicobacter pylori eradication Comparison of the efficacy of the amoxicillin and pantoprazole regimen with clarithromycin-based quadruple regimen for Helicobacter pylori eradication 2021-11-22 anticipated 166 Complete https://irct.ir/trial/59538 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the two treatment groups. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment, Blinding description: Intervention (receiving dual therapy regimen or clarithromycin-based quadruple regimen) and patient evaluation will be carried out by a physician who is blinded to placement in treatment groups. Also patients and statistical analyzer will not know about patient grouping. 3 Helicobacter pylori infection. Intervention 1: Intervention group: (dual regimen): amoxicillin 1000 mg every 12 hours (Farabi pharmaceutical CO., Iran) and pantoprazole 40 mg every 12 hours (Tehranchemie CO., Iran) for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed for Helicobacter pylori eradication. Intervention 2: Control group: (quadruple regimen): clarithromycin (Loghman pharmaceutical CO., Iran) 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours (Farabi pharmaceutical CO., Iran), bismuth subcitrate (Aria Co., Iran) 240 mg every 12 hours and pantoprazole 40 mg every 12 hours (Tehranchemie CO., Iran) for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed for Helicobacter pylori eradication. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Samira Mohammadi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 mohammadi.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Samira Mohammadi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 mohammadi.s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years Confirm diagnosis of H. pylori infection by stool antigen test No previous treatment of H. pylori infection Patient consent to participate in the study 18 years no limit Both Use of antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs) in the last 4 weeks allergy to any of the studied drugs History of gastric surgery or the presence of a serious concomitant disease such as cancer, Pregnant or lactating women B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: (dual regimen): amoxicillin 1000 mg every 12 hours (Farabi pharmaceutical CO., Iran) and pantoprazole 40 mg every 12 hours (Tehranchemie CO., Iran) for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed for Helicobacter pylori eradication. Control group: (quadruple regimen): clarithromycin (Loghman pharmaceutical CO., Iran) 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours (Farabi pharmaceutical CO., Iran), bismuth subcitrate (Aria Co., Iran) 240 mg every 12 hours and pantoprazole 40 mg every 12 hours (Tehranchemie CO., Iran) for 14 days and then pantoprazole 40 mg every 12 hours for 4 weeks will be prescribed for Helicobacter pylori eradication. Presence of Helicobacter pylori infection. Timepoint: Two weeks after the end of treatment. Method of measurement: Assess the presence of infection based on Stool Antigen Test. Treatment complication. Timepoint: Patients clinical visits every two weeks and fallow up by phone call every week. Method of measurement: Presence of nausea, vomiting and any allergic reactions based on clinical information. Ahvaz University of Medical Sciences Approved 2021-10-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)